Meet Inspiring Speakers and Experts at our 3000+ Global Events with over 600+ Conferences, 1200+ Symposiums and 1200+ Workshops on Medical, Pharma, Engineering, Science, Technology and Business.

Explore and learn more about Conference Series LLC Ltd : World’s leading Event Organizer

Conference Series LLC Ltd Conferences gaining more Readers and Visitors

Conference Series LLC Ltd Web Metrics at a Glance

  • 3000+ Global Events
  • 25 Million+ Visitors
  • 25000+ unique visitors per conference
  • 70000+ page views for every individual conference

Unique Opportunity! Online visibility to the Speakers and Experts

Previous Speakers

Christopher J Leintz

Christopher J Leintz

Christopher J Leintz USA

Ronald A Rader

Ronald A Rader

Biotechnology Information Institute USA

Chang-Guo Zhan

Chang-Guo Zhan

University of Kentucky USA

Abe Hershkovitz

Abe Hershkovitz

Hershkovitz & Associates, PLLC USA

Andy Upsall

Andy Upsall

BioOutsource UK

András Guttman

András Guttman

University of Pannonia USA

Gene M. Ransom, III

Gene M. Ransom, III

University of Maryland and University of Baltimore School of Law USA

Timothy J Shea

Timothy J Shea

Sterne, Kessler, Goldstein & Fox P.L.L.C USA

Biosimilars Congress 2018

About conference

 

Biosimilars Conferences is inviting you to attend Biosimilars Congress 2018 on November 14-15 | 2018 Lisbon | Portugal. The topic of the current year's gathering is Biosimilars & Biologics: Present Scenario & Future Prospects which will give a worldwide stage to talk of present and future of Biosimilars. 

Biosimilars Congress 2018 gathering will empower us to continue plunging further into both the examination of Biosimilar change and the business necessities for associations. From around the world, top Biosimilars and Biologics experts meet at the largest networking conference Biosimilars Congress 2018.

The Organizing Committee is satisfied to welcome you to attend the Biosimilars Congress 2018, one of its astonishing Pharmaceutical gatherings to be held in November 14-15 | 2019 in Lisbon | Portugal.

Our Conferences on Biosimilars joins scientists, authorities and CROs from around the world. The Biosimilars Congress 2018 experiences an exponential improvement over the coming couple of years. Various Biologics things are affecting their passage in the pharma to publicize and experiencing a striking climb in their utilization over the standard remedies.

At Biosimilars 2018 meet your planned intrigue bunches from around the world focused on getting some answers concerning Biosimilars and Biologics. This gathering would be your single most obvious opportunity to accomplish the greatest accumulation of individuals from the Biosimilars and Biologics gathering.

Biosimilars Congress 2017 gather was a hit we could get learning from two specific gathering one that surpassed desires in the deliberate and collecting end and one that surpassed desires in the business and key end.

This year’s flagship event will gather top Europe Associations, Societies, Companies, Laboratories, Global regulators, Officials, Healthcare Actors as well as Industry leaders, to foster open exchange and debate on the role of the Biosimilars and Biologics sector in “Biosimilars Congress 2018 : Present Scenario & Future Prospects”.

Why to Attend?

Biosimilars Congress 2018 gives a complete 360-degree overview on Biosimilars and Biologics: Present scenario & Future prospects. Participants will leave the conference with a wealth of new information and an expanded network of contacts.

The Biosimilar is a lucrative sector owing to recent regulatory approvals and increasing opportunities. Biosimilars and Biologics are at different stages of evolution across the globe. Developing a Biosimilars demands huge investment, technical capabilities and clinical trial expertise. In order to unlock the Biosimilars potential, the industry will entail focused strategies along the whole value chain, from optimizing the clinical development program to commercialization.

Biosimilars Conferences developments are maintaining their momentum and the 2018 Biosimilars Conferences programme delves into strategic discussions regarding:

  • Market and regulatory developments in the Europe and globally, enlightened by the perspective of healthcare professionals and patients experiences
  • Pharmacovigilance and clinical practice - what can be learned from the emerging data?
  • The impact of Biosimilars on the competitive landscape of biological products
  • Developing Biosimilars & Biobetters
  • Innovator Pharmaceutical Products of Biosimilars
  • Current Challenges and Research trends in Biosimilars & Biologics
  • Biosimilars: Pharmacovigilance and Safety
  • BCS & IVIVC Based Biowaivers
  • Biopharmaceutical
  • Biological Medicines
  • Bioequivalence Assessment
  • Developing Biosimilars & Biobetters
  • Generics and Biosimilars: Industrial Strategy
  • Globalization of Biosimilars
  • GMP, GCP, QC & R&D
  • Innovation and Technology for Biosimilar Development
  • Intellectual Property Rights
  • Novel Drug Delivery Technologies
  • Pharmacology and Drug Development
  • Plant Produced Biosimilars
  • Protein Biotherapeutics and Biosimilars
  • Regulatory Approach for Biosimilars

Learning objectives

  • Update the participants on the current knowledge including regulatory and scientific thinking
  • Deal with regulatory requirements, scientific and operational challenges
  • Exchange experiences and discuss hot topics with experts
  • Frame the current issues and create dialogue

Key Features

  • Meet Regulatory Expectations
  • Devise Strategies
  • Explore different statistical approaches to demonstrate Biosimilarity with the reference product
  • Panel Discussion and Extended Q&A Sessions
  • Open forum to discuss your most critical questions around Biosimilars & Biologics
  • National & International Speakers
  • Networking with National and International Industry stalwarts who will inspire, educate and engage in all the aspects of Biosimilars.
  • Gain insights and enhance your knowledge with Biosimilars Congress 2018.
  • Provides interaction with the world's well known CEO's and Directors of the Pharmaceutical companies.

In this limelight, Biosimilars Congress is pleased to announce the “13th International Conference on Biosimilars and Biologics” on November 14-15, 2018 in Lisbon, Portugal. This conference will congregate top industry stalwarts to discuss key challenges and best practices from development to launch of Biosimilars and Biologics of market existence

Biosimilars Conferences unites a one of a kind and International blend of Specialists, Scientists, Researchers, IPR professionalsCROs and CMOs from around the world both from the scholarly world and industry over the globe to trade their insight, experience and research advancements in a single stage. 

Join your companions the world over focused on getting some answers concerning Biologics and Biosimilars related advances, which is your single most obvious opportunity to accomplish the greatest gathering of individuals from the Biosimilars society, coordinate shows, scatter information, meet with recurring pattern and potential specialists, make a sprinkle with new research works, and get name affirmation at this Two-day event. Broadly acclaimed speakers, the most recent research, moves, and the most momentum refreshes in Biologics and Biosimilars are indications of this gathering. Provision of information on new technologies implemented in the field of Biosimilars and a sound knowledge on the Clinical Trail development.

Benefits to Attend!

Benefits to attend Biosimilars Congress 2018

  • Keynote introduction alongside connections to excite established researchers.
  • Workshop and symposiums to achieve the biggest array of members from the Pharma / Biotech people group.
  • A wide track of exhibitors to grandstand the new and rising advancements
  • Platform to worldwide speculation group to interface with partners in Pharma/Biotech area
  • Links to the political promoting assets keeping in mind the end goal to extend your business and research organize
  • Triumph of Awards, Certificates perceives your sense of duty regarding your calling to empower the incipient research.

Biosimilars 2018 Benefits:

Open board exchanges: Providing an open gathering with specialists from the scholarly world and business to talk about on current difficulties in Biosimilars and Biologics, where all participants can collaborate with the board took after by a Q&A session.

Speaker and notice introductions: Providing a stage to all academicians and industry experts to share their exploration contemplations and discoveries through a discourse or a publication introduction.

Editorial executive gathering: Discussing on development and advancement of open access Bioanalysis and Biomedicine International Journals and enlisting board individuals and analysts who can bolster the diary.

Round table gatherings: Providing a stage where industry experts meet scholastic specialists.

Business and Exhibitor Benefits:

Over 50+ organizations and international pavilions will be exhibiting at the Biosimilars 2018 conference. Exhibitors will include equipment manufacturers and suppliers, systems providers, finance and investment firms, R&D companies, project developers, trade associations, and government agencies.

In addition to the products and services you will have access to valuable content, including Keynote Presentations, Product Demonstrations and Educational Sessions from today’s industry leaders.

The Biosimilars Congress 2018 has everything you need, all under one roof, saving you both time and money.   It is the event you cannot afford to miss!

Market Analysis

With 15 years of experience-sharing on scientific assessment, regulatory approval and the introduction of Biosimilars and Biologics in clinical practice, this conference will take us to new uncharted waters in preparing for this new era.

Biosimilars and Biologics have been well versed in the therapeutic areas where they have been used (e.g. rheumatology, gastroenterology) with positive benefits on access to treatment, and therefore on patient outcomes. They are about to enter cancer patient pathways where the anticipated benefits will represent a unique opportunity for re-investment in needed healthcare products and services.

Market and regulatory developments in the Europe and globally, enlightened by the perspective of healthcare professionals’ and patients’ experiences

The impact of Biosimilars and Biologics on the competitive landscape of biological products is huge. The Biosimilar is a lucrative sector owing to recent regulatory approvals and increasing opportunities. Biosimilars are at different stages of evolution across the globe. Developing a Biosimilars demands huge investment, technical capabilities and clinical trial expertise. In order to unlock the Biosimilars potential, the industry will entail focused strategies along the whole value chain, from optimizing the clinical development program to commercialization.

Biosimilar Market in Europe:

Patent expiration and increased use of traditional generic drugs are leading to a shift of focus in the pharmaceutical industry toward investment in specialty drugs and high growth areas such as Biosimilars in Europe. Patent expiry of key product classes and a growing emphasis on cost-effectiveness is making governments switch to affordable alternatives.

The EMA approved four additional Biosimilars in 2016, including three Biosimilars in two new product classes: a biosimilar of Amgen’s Enbrel (etanercept) and two Biosimilars of Sanofi’s Clexane (enoxaparin sodium).  Etanercept is a fusion protein used to treat a variety of autoimmune disorders and enoxaparin sodium is a low-molecular-weight heparin indicated for preventing blood clots.  These additional approvals bring the total of currently authorized Biosimilars in Europe to 22 and the product classes to eight

It was estimated that in 2015, Europe accounted for the largest market share of the global Biosimilars market, followed by Asia Pacific. Here is thus a tremendous opportunity for Biosimilar manufacturers. However, the development of biosimilar drugs is riddled with complexities, from R&D to manufacturing to marketing, and is one of the most expensive propositions in the pharmaceutical industry.

 About 30 companies are actively developing Biosimilars and Biologics are researching on the Biosimilar versions of 16 distinct molecules that will lead to greater competition by 2020, with 8 major biologic medicines expected to lose exclusivity by 2020.

The next five years are going to be an interesting period in the Biosimilars market as a number of Biologic drugs are going to lose their exclusivity.

Biosimilars Market in Asia Pacific:

Asia-Pacific is the fastest growing market for Biosimilars because of low manufacturing expenses, availability of skilled and cheap labor, lenient regulations laid by governments. In fact, governments are encouraging the use of Biosimilars. For example, the government of India provides various necessary and regulatory procedures for the usage of Biosimilars products.

Asia-Pacific Biosimilars Market was worth $0.78 billion in 2016 and estimated to be growing at a CAGR of 39%, to reach $4.05 billion by 2021.

Based on geography the Asia-Pacific market is segmented into various regions namely Japan, China, India and Australia.

India and China are estimated to grow the fastest. Other countries such as South Korea are also expected to record high growth over the next five years. India is one of the largest hubs for the biosimilar industry and observes a presence of over 30 leading firms that operate in the development of Biosimilars, some of which include Dr. Reddy’s Laboratories, Wockhardt, Lupin, Cipla, Avesthagen, Biocon, and Zydus Cadilla.

Global Biosimilars Market:

While the U.S. has approved only one Biosimilar therapeutic; Japan, Australia and Europe have approved six, eight and 19 Biosimilars respectively. Already, Biosimilars have an exemplary safety track record in the E.U., Japan, and Canada where Biosimilars are regularly competing against Biologics for nearly seven years. The E.U. was the first geographic market to develop the process of authorization of Biosimilars, setting an example for many other developing markets to follow suit. As of 2015, the E.U. has approved 19 Biosimilars, out of 21 submissions, mostly for three reference biologics such as Somatropin, Epoetin alfa and Filgrastim.

Biosimilars generated revenues of $1.1 million in 2007 and gradually rose to $86.9 million in 2014. During this period, the market penetration of Biosimilars in Europe and emerging markets was only about 8%. The top five biologics targeted most by biosimilar developers are Avastin, Enbrel, Herceptin, Humira and Rituxan, which together generate revenues of about $50 billion annually.

Conclusion: Like most other markets, a competitive Biologics market can offer benefits to consumers by lowering prices and enhancing quality. In addition, Biosimilars have an unblemished safety track record in the E.U., where Biosimilars have been competing against biologics since 2006. Biosimilars have also proved to have a notable impact on drug prices. In the E.U., where Biosimilars are already competing with biologics, Biosimilars are sold at a 30% discount compared to branded biologic drugs.

Though Biosimilars industry faces many challenges like Patent and Legal Issues, Production Bottlenecks, Pricing Issue, Regulatory issues and lack of awareness.

In spite of the approval of 21 Biosimilars in Europe, only 18% of the physicians are aware of these similar versions of biologics. However Bisimilars industry seems to have a bright future as an alternative to patent Biologics.

Over two days, participants will dive into a dynamic programme – a crossroads between technical, scientific, market discussions and the overarching healthcare policy agenda on Biosimilars and Biologics.

Sessions and Tracks

Trcak-1: Biosimilar & Biologics: Analytical Strategies & Market Analysis

Effective management of a current good manufacturing practice (GMP) facility requires a strict eye on all those factors. This also includes Bioanalytical methods, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs. Analysis of Biosimilars and Biologics forms to be one of the most important aspects towards the Biologics and Biosimilar development process. On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry. The market for Biosimilars follow-on-Biologics is expected to grow at an exponential rate for next decade with the expiry of most patented drugs by 2020.The market in the APAC region for Biosimilars reached $605 million in 2010 and $683 million in 2011. The market is expected to reach $1.1 billion by 2016, a CAGR of 10.3%. The market in the United States for Biosimilars reached $507 million in 2010 and $1.1 billion in 2011. The market is expected to reach $1.3 billion by 2016, a CAGR of 4.1%.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

SubTracks:

  1. Biosimilar bioanalytical methods
  2. Biosimilar Formulation
  3. Bioassay for comparability and Potency Testing
  4. Biosimilar GMP protein analysis
  5. Biosimilar lc/ms analysis for discovery, preclinical, and clinical programs
  6. Biosimilar Electrophoresis
  7. Biosimilar multimodal techniques
  8. Biosimilars companies                                                                                                                       

Track-2: Biosimilars & Biologics: Clinical Studies & Trials

This track includes Clinical Studies & Trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, Toxicological studies and Aspects of genotoxicity tests. Clinical trials are designed in stages I-IV so as to receive a clear picture of the drug candidate in respect to its pharmacokinetics and pharmacodynamics parameters. Research estimates that there are 280 Biosimilars in the pipeline, and clinical trials are increasing by 20% per year. Biologics also represent over 40 percent of the drugs in each of the preclinical, Phase I, Phase II, and Phase III trial stages.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

SubTracks:

  1. Clinical trials on major diseases
  2. Risk management, and quality affairs
  3. Case studies and clinical models
  4. Transgenic Animals
  5. Targeted cell line development
  6. Clinical PK/PD studies
  7. Toxicological studies
  8. Aspects of Genotoxicity tests
  9. Environmental Monitoring and Microbiological Testing

Track-3: Biosimilars: Innovator Pharmaceutical Products

Biosimilars is a Biologic medical product which is copy of an original product that is manufactured by a different company. Biosimilars are officially approved "innovative" versions of original products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. This session also finds place for all the Biosimilar Exhibitors associated with the field of Biosimilar and Biologics.2014 was a banner year for orphan drugs, which are drugs that treat "rare" diseases/disorders affecting fewer than 200,000 people in the U.S. A total of 41 new molecular entities (NMEs) and biologics (BLAs) were approved by the FDA in 2014 - 15 of those were approved in December alone (11 in final two weeks.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

SubTracks:

  1. Biotechnology medicinal products for different drugs
  2. Challenges faced in developing Biosimilars
  3. Future of Biosimilars
  4. Biopharmaceuticals development
  5. Lyophilization of Biosimilars
  6. Next generation Biosimilars

Track-4: Biosimilars & Biologics: Current Challenges

The generic version of Biologicals- “Biosimilars” is the new buzz word in the world of pharmaceutical industry. Biosimilars are highly similar to their licensed reference product not withstanding minor differences as excipients in the formulation; also there are no remarkable differences between the Biologicals and the reference product in terms of safety, purity, and potency. However, there are certain challenges in way of its development and receiving a green signal for launching into the market. Newer biologics also are targeting widespread diseases, with profound implications: a drug that costs $20,000 per year that is useful for 1 person in 100,000 has much less effect on a health plan’s cost structure than a $5,000-per-year drug that is useful for 1 in 100 people.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

SubTracks:

  1. Current concepts of drugs and Biologics
  2. Unique considerations for Biologics
  3. Early clinical development essentials
  4. Late clinical development essentials
  5. Drug safety essentials
  6. Cancer Therapeutics
  7. Comparability for Biologics
  8. Quality by Design for Biologics and Biosimilars

Track-5: Biosimilars: Pharmacovigilance and Safety

Biosimilar guidelines for Pharmacovigilance practice and Pharmacoepidemiology are the points that shall be laid emphasis in this session. U.S. average annual spending growth from 2002 to 2007 was 16% for biologics, compared with 3.7% for drugs. In same proportion Pharmacovigilance for Biosimilars has been comparatively more than other pharmaceutical products. Biosimilars are interlinked with FDA activities that have as of now been declared to incorporate upgraded following and follow-up of post market issues, arranged changes in AERS, and pilots of new post advertise medicate observing systems. Current difficulties in Pharmacovigilance, adverse medication responses with pharmaceutical items, Biosimilar rules for Pharmacovigilance practice and pharmacoepidemiology are the focuses that should be laid accentuation in this session.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

SubTracks:

  1. Current problems in Pharmacovigilance
  2. Adverse drug reactions with Pharmaceutical products
  3. Detection and evaluation of drug safety signals
  4. Improve Pharmacovigilance through Patient and Provider Education
  5. Regulatory updates and key drivers for registration approvals in US, EU and China
  6. Regulatory requirement for Biosimilar IND filing in the US
  7. Role of Pharma industries in the improvement of Pharmacovigilance system

Track-6: BCS & IVIVC Based Biowaivers

The objective of this track is to suggest the Biowaivers potential of Biopharmaceutical classification system which is known to increase the solubility, dissolution, oral absorption of water insoluble drugs. Biopharmaceutics Classification System and Invitro and Invivo classification discusses about ADME pathways of different drugs. This track also includes BCS biowaivers, in vitro diffusion cells for dissolution testing in formulation development, in vitro preclinical ADME/BCS testing. Until in vitro in vivo correlation achieves the required degree, the Biosimilar drug will not be able to meet the needs of the original drug candidate. Hence the proportion of BCS and IVIVC based biowaivers are fairly low ~0.5-1% of total pharmaceutical products.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. BCS biowaivers
  2. Preclinical and clinical testing for oral drug delivery
  3. Waiver for In vivo Bioavailability or Bioequivalence
  4. Consideration of Biowaiver extensions for BCS class III drugs
  5. In vitro diffusion cells for dissolution testing in formulation development
  6. Dissolution testing in drug formulation
  7. In vitro preclinical ADME/BCS testing
  8. In vitro drug product research

Track-7: Biopharmaceutical

Biopharmaceutical are also called medical product these Biopharmaceuticals includes blood, blood components, gene therapy, Recombinant therapeutic protein. Biopharmaceutical informatics is used in information technology, molecular modeling and biologic drug development. Development of databases containing the experimental data on biophysical stability, safety along with molecular sequence

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Applications of computation in Biologic drug development
  2. Protein sequence-structural contexts and degradation reaction mechanisms
  3. Creation of databases and data mining
  4. Pre-clinical immunogenicity risk assessment of Biotherapeutics
  5. Monoclonal antibodies (Various)
  6. Blood components
  7. Vaccines
  8. Biopharmaceutical Research
  9. Pharmaceutical Microbiology

Track-8: Biological Medicines

Biological Medicine works with the biology of the body and its natural healing capabilities as well as the spiritual, emotional and physical aspects of disease. Disease means that the body’s regulation is not working properly and needs to be brought back into its natural dynamic state where the immune system is in full regulation.  It therefore looks for root causes for the presenting symptoms of disease the underlying factors causing a person to present with a certain illness.  These root causes may consist of several factors which have built up over time and can include; diet, food allergies, intestinal disturbances, family history, stress, environmental factors, heavy metals, dental problems, hyperacidity, trauma, exposure to bacteria or viruses or electromagnetic disturbances.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Advances in Biological products
  2. Biological drugs
  3. Generic Biological drugs
  4. Biotechnology medicinal products for different drugs
  5. Future of next generation Biosimilars
  6. Biopharmaceuticals development

Track-9: Bioequivalence Assessment

Bioequivalence focuses on the equivalence of release of the active pharmaceutical ingredient from the pharmaceutical product and its subsequent absorption into the systemic circulation. This session has utmost importance in context to the fact that only a suitably bioequivalent drug candidate that conforms the results in all respects to the original licensed product can be called as biosimilar drug. Of all attempts towards developing a follow on biologics or a biosimilar drug the main detection point stands at the Bioequivalence Assessment. Once the bioequivalence has been obtained it can be 70% ascertained the drug qualifies to be a suitable biologics or Biosimilars.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Strategies for the bioequivalence assessment of topical dosage forms
  2. Bioequivalence assessment of respiratory dosage forms
  3. Bioequivalence approaches for transdermal dosage forms
  4. Evaluation of highly variable drugs and drug products

Track-10: Developing Biosimilars & Biobetters

Biosimilars are surmounting pharmaceutical business division from most recent three decades and deals appear to extend coherently. Advances in the biotechnology prompt to change and exposure of new natural items (biosimilars) to treat diverse life-debilitating illnesses. Biosimilars are organic medications that are conveyed after expiry of the patent of affirmed pioneer and include Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics through Abbreviated New Drug Applications (ANDAs).

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Key Aspects in Technical Development
  2. Analysis of the Biosimilar Development Pipeline
  3. Legal Issues and Implementation of the BPCI Act

Track-11: Generics and Biosimilars: Industrial Strategy

The "Generic Drugs Market: 2015 - 2030 - Opportunities, Challenges, Strategies & Forecasts" report presents an in-depth assessment of the generic drugs and Analysis of key therapeutic areas and leading generic drugs  pufecosystem including technology, economics, key trends, market drivers, challenges, investment potential, regulatory landscape, leading therapies, Pharmaceutical Industry  opportunities, future road map, Following key trends, market drivers, challenges, Analysis of key therapeutic areas and leading generic trends ,value chain, ecosystem player profiles and strategies and  Regulatory landscape of global trends  throughout the globe The report also presents market size forecasts for generic drugs from 2017 through to 2030. The forecasts are segmented for over 10 therapeutic areas, 3 brand classifications, 5 regions and 25 leading countries.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Clinical development strategies for Biosimilars
  2. Advances in Biosimilar Production & Technologies
  3. Scale Up of Biosimilars
  4. Business Development in biosimilar
  5. Major market trends & Featured regional market trends

Track-12: Globalization of Biosimilars

Globalization of Biosimilars is about the generic drugs impact on Global Biosimilar market, Cost and risk management, adopting innovative mechanisms such as risk-sharing arrangement, European market for Biosimilars. A growing global market for Biosimilars is gaining momentum in response to the expiration of patents for a number of key biologics and consumer demand to reduce treatment costs. Thus, according to Research and Markets, the global biosimilar market, valued at $2 billion in 2012 is projected to reach $19.4 billion by 2018.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Global impact of Biosimilars over generics
  2. Economic aspect towards Biosimilars
  3. Biosimilars in global market
  4. Investment and returns on Biosimilars
  5. Cost and risk management
  6. Adopting innovative mechanisms such as risk-sharing arrangement
  7. European market for Biosimilars
  8. Global P&R models for the Biosimilars and generics market

Track-13: GMP, GCP, QC & R&D

Good Manufacturing Practice is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. Good Manufacturing practices conference aims at both production and Quality Control. Fact about Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. Over the previous decade, a developing offer of the business' R&D yield has comprised of incremental enhancements to existing generic medications instead of new sub-atomic substances. Execution measures that consider just altogether new medications, for example, the quantity of NME endorsements every year miss that move and underestimate the business' R&D Field

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. New Product Development
  2. Patent innovations
  3. The Global R & D and Regulatory Landscape
  4. Regulatory landscape of generic drugs throughout the globe
  5. Facts about Current Good Manufacturing Practices (cGMPs)
  6. Current GMP guidelines
  7. Good clinical practices & Good Laboratory Practices
  8. Current regulations and quality Standards
  9. International Regulatory Affairs

Track-14: Innovation and Technology for Biosimilar Development

A biosimilar is an organic item very like an affirmed natural item, known as a kind of perspective item, with no clinically significant contrasts as far as wellbeing and viability. In the U.S., if a natural compound exhibits practically identical information to a U.S. Nourishment and Drug Administration (FDA)- authorized item from expository, preclinical and clinical reviews, it will be acknowledged as a biosimilar after termination of trend-setter licenses through a curtailed course. Tradable natural items are likewise Biosimilars, however should meet extra criteria to coordinate the reference item. Interchangeable can be substituted for the reference item without a medicine from a social insurance supplier.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Biosimilar Product Reimbursement and Pricing
  2. Biosimilar Regulatory Updates and Legal Implications
  3. Biosimilar Market Access and Commercialization

Track-15: Intellectual Property Rights

The safeguarding of product trade secret, its formulations and other process parameters by law is usually covered by IPR. It includes those as patents, copyrights, industrial design rights, trademarks etc. IPR is of prime importance in the field of Biologics and Biosimilars. Most scientist and industries tend to retain their monopoly business by exercising the IPR. Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law. Eight years of exclusivity would keep biologic medicines out of the hands of many who need them. Prices frequently exceed $100,000.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Pharma patent scenario
  2. Criteria for patentability and patent claims
  3. Critical research issues
  4. Patentable subject matter
  5. Recent patent disputes and litigations

Track-16: Novel Drug Delivery Technologies

Biosimilar Engineers and their outsourcing accomplices must know about the picked nation's administrative scene, and have broad information of any current Biosimilar endorsement pathway and the most recent administrative organization rules. Furnishing administrative experts with endorsements of investigation (CoA) for a U.S. - advertised comparator could challenge. As opposed to European practice, U.S. makers tend not to make CoAs accessible to parties required in the production network or bolster the improvement of a contender by discharging CoAs for clumps acquired for clinical trials. Giving family proclamations to the reference item more often than not is acknowledged as an option.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Product Similarity for Biosimilars & Analytical Challenges
  2. Role of Medical Affairs in Biosimilars
  3. Regulatory strategy for generics and Biosimilars

Track-17: Pharmacology and Drug Development

Pharmacology is the branch of solution and science worried with the investigation of medication action where a medication can be comprehensively characterized as any man-made, characteristic, or endogenous (from inside body) particle which applies a biochemical and additionally physiological impact on the cell, tissue, organ, or living being (once in a while the word Pharmacon is utilized as a term to envelop these endogenous and exogenous bioactive species). Sedate improvement is the way toward conveying another pharmaceutical medication to the market once a lead compound has been distinguished through the procedure of medication revelation. It incorporates pre-clinical research on microorganisms and creatures, petitioning for administrative status, for example, by means of the United States Food and Drug Administration for an investigational new generic medication to start clinical trials on people, and may incorporate the progression of acquiring administrative endorsement with another medication application to showcase the medications and Increase Global Pharma Market

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Clinical pharmacology and Drug addictions
  2. Characterization of biologically active compounds
  3. Recent advancements in research and developments
  4. Recent advances in computer aided drug design
  5. Novel Approaches in drug discovery

Track-18: Plant Produced Biosimilars

Biosimilar products are also produced from plants. Plants are the richest store house of diverse class of phytochemicals. Production of Biosimilar products in tobacco plants is on the verge of completion of the first step in their research. These also includes Transgenic plants, Post translational genetics, Fermentation culture, Molecular farming. For biosimilar manufacturers this session has the potential to bring up new avenues in their product range. Pharmacognosy researchers would find this track highly interesting and informative towards their research work. Proportion of plant produced Biosimilars are comparably low. However, an increased level of plant sourced biologics ~25% is owned to be seen in the market. Especially biologics derived from the plant sources are expected to occupy about more than 20% of all biologics.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Transgenic plants
  2. Post translational genetics
  3. Fermentation culture
  4. Molecular farming

Track-19: Protein Biotherapeutics and Biosimilars

Biotherapeutics more often than not alludes to helpful materials created utilizing organic means, including recombinant DNA innovation. Biotherapeutics are fundamentally operators, used to treat and maintain a strategic distance from human malady by interrelating with the microbial environment of the host. Biotherapeutics can target particular particles inside the human body, and have a decent reputation with patient wellbeing. Fabricating biotherapeutics is mind boggling, as they are bigger mixes in both size and structure, and can be touchy to ecological conditions.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Advancements in Biotherapeutics
  2. Biotech and Biosimilar Products
  3. Antibody based therapeutics
  4. Therapeutic Antibodies and Fc Fusion Proteins

Track-20: Regulatory Approach for Biosimilars

An FDA analysis of drug prices from 1999 to 2004 found that the discount from generic competition was just 6 percent with one generic competitor, but jumps to 48 percent with two generic competitors, 56 percent with three, 61 percent with four and 67 percent with five generic producers in a market. Within two years of the expiration of the patent for the popular drug Zantac in mid-1997, generic versions accounted for 90 percent of the treatment’s total sales, and the price for patients was about 10 percent of its pre-generic price. European patents on biologic treatments began to expire in 2000, and in April 2006, Sandoz and Biopartners received EMEA approval for the first European Biogenerics, two products containing human growth hormone.

Suggested Conferences: Biosimilars Conferences | Biosimilars Congress | Top Biosimilar Conferences | Biosimilars Conferences 2018 | Biosimilar Conferences Europe | Biosimilars Conferences Portugal

Sub Tracks:

  1. Biosimilars regulation
  2. BLA filing for Biosimilars
  3. Regulatory prospects of BRIC countries
  4. Aparadigm of traditional generics to Biosimilars
  5. Biowaiver approval for Biosimilars
  6. Generic Biosimilars
  7. Regulatory Prospects in BRIC countries

Who Will Attend?

Target Audience:

  • Executives, CEO's of Industries & Organizations
  • Business Development Managers
  • Boss Scientific Officers
  • Research and development Researchers from Biosimilars and Biologics Industries
  • Educators, Associate Professors, Assistant Professors
  • PhD Scholars
  • Patent Attorneys
  • Protected innovation Attorneys
  • Speculation Analysts
  • Affiliation, Association presidents and experts
  • Honorable laureates in Health Care and Medicine
  • Bio instruments Professionals
  • Bio-informatics Professionals
  • Programming improvement organizations
  • Research Institutes and individuals
  • Inventory network organizations
  • Assembling Companies
  • CRO (Contract Research Organization) and DATA administration Companies
  • Preparing Institutes
  • Business Entrepreneurs

Few Global Universities for Biosimilars:

  • University of California, USA
  • North Carolina State University, USA
  • University of London, UK
  • Biotechnology Information Institute, USA
  • University of Toronto, Canada
  • Biotechnology Information Institute, USA
  • USC Keck School of Medicine, USA
  • University of La Sabana, Colombia
  • University of Pannonia, USA
  • USC Keck School of Medicine, USA
  • Touro College of Pharmacy, USA

Global Societies and Associations in Europe:

  • Medicines for Europe 
  • British Biosimilars Association (BBA) 
  • European Medicines Agency
  • European Association of Hospital Pharmacists
  • International generic and Biosimilar Medicines Association (IGBA)
  • Nanotechnology Industries Association
  • Royal Microscopical Society
  • Royal Society - Nanotechnology and Nanoscience
  • British Society for Nanomedicine
  • Belgian Society of Pharmaceutical Sciences (BGFW)
  • European Federation for Pharmaceutical Sciences (EUFEPS)
  • Italian Society for Pharmaceutical Sciences (SISF)
  • Association of the British Pharmaceutical Industry (ABPI)
  • A Division of the Association for Accessibility medicines (DAAM)
  • European Biopharmaceutical Trade Association
  • Biosimilars - Generic Pharmaceutical Association
  • European Generic Medicines Association.

Global Societies and Associations in the USA:

  • The Biosimilars Council
  • Association for Accessible Medicines
  • Biosimilars Resource Center (BRC) 
  • American Academy of Nanomedicine
  • American Nano Society
  • American Society for Nanomedicine
  • Canadian Society for Pharmaceutical Sciences (CSPS)
  • Pharmaceutical Manufacturers Association of Canada (PMAC)
  • American Association of Pharmacy Technicians (AAPT),
  • American Society of Health-System Pharmacists (ASHYP)
  • Canadian Society of Intestinal research (CSIR)                                                                                                                                                        

Global Societies and Associations in Asia:

  • National Center for Nanoscience and Technology
  • Indian Society for Nanomedicine
  • Nano Technology Research Association
  • Indian Society of Nanomedicine
  • The Pharmaceutical Society of Australia (PSA)
  • Austrian Pharmaceutical Society (APS)
  • Korean Research-based Pharmaceutical Industry Association (KRPIA)
  • Kuwait Pharmaceutical Association (KPA)

Past Conference Report

Biosimilars-euro 2017

Conference Series hosted the 7th European Biosimilars Congress at Novotel Munchen City Arnulfpark Munich, Germany during May 15-16, 2017.The conference was designed around the theme of “The developmental strategies and uptake of biosimilars through a decade in Europe” and was a great success where eminent keynote speakers from various reputed companies made their resplendent presence and addressed the gathering. Moreover, the networking sessions laid the foundation for some time worthy collaborations between many start-up and big industries. The post conference networking lunch session witnessed a number of B2B meetings that are turning up to be mutually beneficial to both the organizations who had gone in for the business meetings.

Euro Biosimilars 2017 witnessed an amalgamation of peerless speakers who enlightened the crowd with their knowledge and confabulated on various new-fangled topics related to the field of Biologics and Biosimilars. This congress not only brought forward the latest developments in the field but also provided solutions to the numerous challenges encountered in developing a biosimilar.

Conference Series would like to convey a warm gratitude to all the Honourable guests, Keynote Speakers, Delegates, Media Partners and Exhibitors for their participation in Euro Biosimilars 2017.

  • Christoph Volpers, Michalski & Hüttermann, Germany
  • Arthur G Cook, ZS Associates, USA
  • Tim Demuth, Sandoz Pharmaceuticals GmbH, Germany
  • Rosa Helena Bustos, University of La Sabana, Colombia
  • Ulrike Konrad, Protagen Protein Services , Germany
  • Stanley Seung Suh Hong, Celltrion Healthcare Co. Ltd., South Korea
  • Ulrich Storz, Michalski Huttermann & Partner, Germany

We on behalf of the conference specially thank the exhibitors for their participation in the congress and also the media partners for their wonderful marketing of the event. Conference Series also took the privilege of felicitating Euro Biosimilars 2017 Organizing Committee, Keynote Speakers and Chair whose support made conference a great success.

With the enormous feedback from the participants and supporters of Euro Biosimilars 2017, we are glad to announce 13thInternational Conference on Biosimilars and Biologics  during November 14-15, 2018 in Lisbon, Portugal

                            See you next year at Lisbon,Portugal

For More details visit:  https://biosimilars.annualcongress.com/


Past Reports  Gallery  

To Collaborate Scientific Professionals around the World

Conference Date November 14-15 | 2018

For Sponsors & Exhibitors

sponsors@conferenceseries.com

Speaker Opportunity

Supported By

Journal of Bioequivalence & Bioavailability Journal of Bioanalysis & Biomedicine Journal of Pharmacovigilance Advances in Pharmacoepidemiology and Drug Safety

All accepted abstracts will be published in respective Conference Series LLC LTD International Journals.

Abstracts will be provided with Digital Object Identifier by


Media partners & Collaborators & Sponsors

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Collaboration

Past Affiliations

Speaker Logos
Speaker Logos
Speaker Logos
Speaker Logos
Speaker Logos
Speaker Logos

Keytopics

  • Abbreviated Clinical Trial Designs
  • Analytical Strategies For Biosimilars
  • BCS Based Biowaivers
  • Bio Similar Innovative Devices
  • Bioequivalence Assessment
  • Biological Licenses
  • Biosimilar Companies
  • Biosimilar Cost Analysis
  • Biosimilar Manufacturer Strategies
  • Biosimilar Market
  • Biosimilar Medicines
  • Biosimilar Product Development
  • Biosimilars And Biologics
  • Biosimilars And Their Social Repercussions
  • Biosimilars Approved In Europe
  • Biosimilars Approved In US
  • Biosimilars Economic Predictions
  • Biosimilars In Developing Countries
  • Biosimilars Manufacturing Process
  • Biosimilars Research Pipeline
  • Challenges In Biosimilars Pharmacovigilance
  • Clinical Development Of Biosimilars
  • Commercial Landscape In Biosimilars
  • Comparison Of Biologic Drug Prices
  • Consequences Of Brexit On Biosimilars
  • Current Challenges In Developing Biosimilars
  • Differences Between Biosimilars And Generic Drugs
  • Emerging Biosimilars In Therapeutics
  • Fingerprinting Analysis
  • Future Of Biosimilars
  • Globalization Of Biosimilars
  • Health Technology Assesment Of Biosimilars
  • Innovative Approach For Biosimilars
  • Intellectual Property Rights
  • Interchangeability Of Biosimilars
  • Investigator Initiated Biosimilar Research
  • IVIVC Based Biowaivers
  • Laws On Biologics Regulation
  • Legal Issues And BPCI Act
  • Market Analysis Of Biosimilars
  • Need For Biosimilars
  • New Pathway For Biosimilars
  • Outlook On Biosimilars
  • Patient Safety In Biosimilars
  • Quality Considerations For Biosimilars Biosimilars
  • Reimbursement And Coding In Biosimilars
  • Stability Of Biosimilars
  • Substitution Of Biosimilars
  • The Savings Potential Of Biosimilars
  • Therapeutic Efficiency Of Biosimilars
  • What Are MAbs Biosimilars?
  • What Is A Biologic Medicine?
  • What Is A Biosimilar Medicine?
  • Worldwide Regulatory Status Of Biosimilars