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.

 

  • Current concepts of drugs and Biologics
  • Unique considerations for Biologics
  • Early clinical development essentials
  • Late clinical development essentials
  • Drug safety essentials
  • Cancer Therapeutics
  • Comparability for Biologics
  • Quality by Design for Biologics and Biosimilars

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