Current Agency Expectations for Approval for Biosimilars

 

 

<p justify;"="" style="text-align: justify;">Biosimilars are a relatively new subset of biopharmaceuticals, with the biotechnology industry finally maturing such that off-patent generic-type products increasingly will be entering major markets. So far, more than 20 Biosimilars for a limited number of reference products have been approved in major markets, primarily the European Union. Only two products have been formally approved as Biosimilars in the United States. The parent field of biopharmaceuticals itself continues to exhibit a poor supporting infrastructure of information resources. Those biopharmaceutical and biosimilar information resources that do exist generally are limited in number, diversity, and sophistication.

  • Drug safety of Biosimilars products
  • Regulatory aspects
  • Regulatory affairs and IPR of Biosimilars products

Related Conference of Current Agency Expectations for Approval for Biosimilars

February 28-March 01, 2019

Global Pharmaceutical and Pharma Industry Conference

Osaka, Japan
March 18-20, 2019

18th World Pharma Congress

Edinburgh, Scotland
March 18-19, 2019

13th International Conference on Biosimilars and Biologics

Amsterdam | Netherlands
July 26-27, 2019

13th Asian Biologics and Biosimilars Congress

Melbourne, Australia

Current Agency Expectations for Approval for Biosimilars Conference Speakers

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