Biologics & Biosimilars

Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA. Under U.S. law, a biosimilar is approved based on a showing that it is “highly similar” to an FDA-approved biological product, known as a reference product. It may not have any clinically meaningful differences in terms of safety and effectiveness from the reference product.

 

  • Bio-analytics for biosimilars
  • Extrapolation and Interchangeability
  • Legal considerations for biosimilars
  • Biosimilar uptake and market considerations
  • Challenges and regulatory approach for biosimilars
  • Future of next generation biosimilars

Related Conference of Biologics & Biosimilars

October 18-20, 2018

18th World Pharma Congress

Warsaw, Poland
February 28-March 01, 2019

Global Pharmaceutical & Pharma Industry Conference

Osaka, Japan
March 18-19, 2019

13th International Conference on Biosimilars and Biologics

Amsterdam | Netherlands
August 5-6, 2019

13th Asian Biologics and Biosimilars Congress

Melbourne, Australia

Biologics & Biosimilars Conference Speakers

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