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