Biosimilars are a fascinating new category of medication and are quickly becoming part of the rheumatologist’s treatment armamentarium, but they can be confusing to understand. This episode will enhance your knowledge of this new class of medications by providing a better understanding of how biologics differ from most other medications, and why biosimilars aren’t just generics of biologics. This episode also takes a brief look into the history of drug regulation with a focus on biosimilars and how they’re FDA approved.

• Intro :12
• What is a biologic? 1:21
• What makes a generic? 5:05
  • History of drug regulation in the U.S. 5:10
• What makes a biologic? 11:43
  • Monoclonal antibodies 11:51
• Where do biosimilars come from? 14:16
  • Definition 15:03
  • Manufacturing process 15:17
  • FDA approval process 16:00
• Trials of biosimilars 19:44

We’d love to hear from you! Send your comments/questions to [email protected].

Resources:

Bridges SL Jr., et al. Arthritis Rheumatol. 2018;doi:10.1002/art.40388.

Hornecker JR. Generic Drugs: History, Approval Process, and Current Challenges. U.S. Pharmacist. 2009;34(6)(Generic Drug Review suppl):26-30.  

Janssen WF. The Story of the Laws Behind the Labels. https://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/FOrgsHistory/EvolvingPowers/UCM593437.pdf. Published June 1981. Accessed April 14, 2018.

Liu JKH. Ann Med Surg (London). 2014;doi:10.1016/j.amsu.2014.09.001.

Morrow T, Felcone LH. Biotechnol Healthc. 2014;1:24-26,28-29.