Discussion Held on Biosimilars

The Atlantic Policy Briefing www.theatlantic.com held March 15, 2017 in Washington D.C., brought together stakeholders from government and the private sector to discuss the changing role for biosimilars and how biosimilars will be affected in the future both domestically and abroad.

A biosimilar product is a biological product that is approved based on showing that it is highly similar to an FDA www.fda.gov approved biological product known as a reference product. A biosimilar product also has to show that there are no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Representative Michael Burgess MD (R-TX) http://burgess.house.gov began the briefing conducted by Joie Chen Journalist and Contributor to AtlanticLive by saying, “We need to effectively get more approvals for biosimilars by streamlining the approval process.”

As Representative Burgess explained, “So far, only four drugs have made it through the approval process. Congress plays an important role in dealing with biosimilars but the role for Congress isn’t to decide specifically what drugs get approved but to work to expand the biosimilar field by dealing with other issues to help the biosimilar community.

A panel discussion was held with Jim Van Lieshout, VP, Market Access and Pharmacy Strategy, Apobiologix www.apobiologix.com, Len Lichtenfeld MD, Deputy CMO, American Cancer Society www.cancer.org, and with David Fox, Partner, Hogan Lovells www.hoganlovells.com  with Joie Chen as moderator.

The panel addressed interchangeability of drugs when dealing with biosimilars since patients might be switched from one drug to another. In that case, the doctor and patient have to be assured that the new drug would be effective and safe to use.

To deal with interchangeability, on January 18, 2017, FDA released a draft guidance document in the Federal Register titled “Considerations in Demonstrating Interchangeability with a Reference Product.” The purpose for the document is to demonstrate how a product can be interchanged with a reference product before submitting a marketing application.

Dr. Lichtenfeld pointed out, “Interchangeability is not too important in short term acute care situations, but gains importance when the medical professions is dealing with patients affected with long term chronic conditions.”

Summing up, FDA and the biosimilar community needs to give further thought to reducing prices for biosimilars and whether there are any new innovations that would keep biosimilars truly viable in the marketplace.