FDA Hosts Webinar on Biosimilar Approval Process, Looks Ahead to Interchangeability

This week, Leah Christl, PhD, associate director for therapeutic biologics, Center for Drug Evaluation and Research (CDER), FDA, and Sue Lim, MD, medical officer at the FDA’s Office of New Drugs, held a webinar to discuss the regulatory framework for biosimilars as well as the development and approval process for these drugs.

Christl delivered the main portion of the presentation, beginning by discussing the background of biosimilars, and announced that, as of December 1, 60 programs are enrolled in the Biosimilar Product Development (BPD). CDER has also received meeting requests to discuss the development of biosimilars for 27 reference products, and 11 companies have publicly announced submission of 20 individual 351(k) Biologics License Applications (BLAs) to the FDA since December 1, 2017.

Among the key concepts highlighted were the following:

• The goals of stand-alone and biosimilar development programs are different: stand-alone programs are meant to demonstrate safety and efficacy, while biosimilar programs are meant to demonstrate biosimilarity to a reference product.
• A totality-of-the-evidence approach is used in evaluating biosimilarity, and there is no “one-size-fits-all” assessment
• The scope of the clinical studies depends on the extent of residual uncertainty about the biosimilarity of the 2 products after conducting structural and functional characterization and comparative animal studies.
• The potential exists for a biosimilar product to be approved for 1 or more indications of use for which the reference product is licensed, based on extrapolation

Finally, the webinar summarized general principles about the licensing of biosimilars as interchangeable products:

• When a product is first licensed as a biosimilar, that licensure may be referenced when applying for interchangeability approval in order to support a showing for statutory criteria to demonstrate interchangeability.
• The FDA expects sponsors to submit data and information to support a showing that the proposed interchangeable product is interchangeable in all the reference’s licensed conditions of use.
• Applications for a product administered more than once to an individual generally include data from a switching study or studies in 1 or more appropriate conditions of use.
• The evaluation of proposed product presentations will include product design and user interface relative to the reference product.

The webinar concluded with a question-and-answer section, and the PowerPoint and transcript of the presentation can be found online at the FDA’s website.