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

August 20-21, 2018

12th Asian Biologics and Biosimilars Congress

Tokyo, Japan
August 29-30, 2018 |

International Conference and Exhibition on Drug Safety & Pharmacovigilance

Park Inn By Radisson Toronto Airport West, 175 Derry Road East, Mississauga, ON, L5T 2Z7, Canada
October 18-20, 2018

18th World Pharma Congress

Warsaw, Poland
November 14-15 | 2018

13th International Conference on Biosimilars and Biologics

Lisbon | Portugal
September 18-19, 2018

6 th European Biopharma Congress

Amsterdam, Netherlands

Biologics & Biosimilars Conference Speakers

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