As reported in Generics Bulletin October 10th, Dr. Sarah McMullen, India country director for the US Food and Drug Administration underscored that there’s no real distinction in the standards to determine the safety or efficacy for both biosimilars and interchangeable biosimilars, and put forth a “fact check” to dispel the general notion among patients that interchangeables are perhaps better than other approved biosimilars.
Dr. McMullen’s remarks were made while addressing the BioPharma Conclave 2022, and echo those made by Leah Christl, Executive Director of Biosimilars Global Regulatory and R&D Policy at Amgen, in a July 20 webinar hosted by ASBM and GaBI Journal. Dr. Christl, former Director of Therapeutic Biosimilars and Biologics at the FDA’s Office of New Drugs, said in her presentation:
This designation of a biosimilar as interchangeable does not imply anything about the quality of the product. Non-interchangeable biosimilars are held to the same standards as interchangeable biosimilars…an interchangeable is not a quote-unquote “better” biosimilar, it’s just a biosimilar that’s undergone additional testing to generate additional data and information to support meeting the statutory definition and ultimately be eligible for pharmacy-level substitution.
The webinar, entitled “Non-medical switching of biologicals/biosimilars: Canada, Europe and the US” is the subject of a Meeting Report to be published in the next issue of GaBI Journal.
View a recording of the ASBM/GaBI Webinar featuring Dr. Christl’s presentation, here.
Read the full article about the FDA comments at Generics Bulletin here (registration required).