On November 18, the Biologic Prescribers Collaborative, along with the Institute for Patient Access and the Alliance for Patient Access hosted its fifth annual National Policy & Virtual Summit on Biologics. As part of the Summit, ASBM Chair Madelaine Feldman, MD, FACR, was interviewed by AfPA’s Gavin Clingham about ASBM’s new whitepaper “US Biosimilars Market on Pace with Europe”; published in GaBI Journal. The paper is co-authored by Dr. Feldman along with ASBM’s Executive Director Michael Reilly.

As Dr. Feldman explains, the paper demonstrates FDA is moving at approximately the same pace as EMA based on the number of approvals at the same time after implementation of its regulatory pathway:

  • As of September 2020, approximately 10 years after implementation of the biosimilar approval pathway, 28 biosimilars have been approved by FDA, with 18 of those approvals granted in the last 2 years. For comparison, in the 10-year time period following the creation of Europe’s biosimilar regulatory pathway, EMA approved just 13 biosimilar products (some of which were marketed under several different brands)
  • Currently, there are 46 biosimilars approved in Europe; however, these estimates fall to 35 when products approved in the US as follow on biologicals via the 505(b)(2) pathway, e.g. somatropin, insulin, teriparatide, or abbreviated new drug application (ANDA) are excluded. Furthermore, Europe’s filgrastim biosimilar Tevagrastim®/Ratiograstim® was approved as Granix® (tbo-filgrastim) in the US via a Biologic License Application (BLA) prior to the implementation of a biosimilars approval pathway and is not included in the US biosimilar count.

In addition, US biosimilars have gained significant share in the majority of therapeutic areas in which they have been introduced, ranging on average from 20% to 25% within the first year of launch, with some projected to reach greater than 50% within the first 2 years:

  • As expected, first-to-market biosimilars tend to capture a greater portion of the segment compared to later entrants. Filgrastim biosimilars have been on the market the longest at 5 years and have achieved a 72% share.
  • Bevacizumab and trastuzumab biosimilars, launched in 2019-2020 have approximately 40% share.
  • Rituximab and infliximab have had the most limited adoption, with approximately 20% market share.

Watch Dr. Feldman’s interview here.

Read the full whitepaper here.

View the entire National Policy & Virtual Summit on Biologics here.