The Center for Biosimilars provided coverage of the National Policy and Advocacy Summit on Biologics and Biosimilars held on April 17, highlighting the comments of Leah Christl, PhD, the associate director for therapeutic biologics at the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. Christl said the United States will see a dramatic increase in the number of biosimilar approvals based on the quantity of applications that the FDA is currently receiving, but the process of approvals has been different than the EU approval process.
“We came in to having this approval pathway later than other areas of the world, and the expectation was that we would have companies bring to us the products that they had approved in other areas and would just seek approval here,” explained Christl. “But, we didn’t see that. What we saw was the global development programs were ongoing, and they were bringing monoclonal antibodies.”
Christl also updated attendees that the FDA’s draft guidance on interchangeability will be made by May 2019 – two years after the comment period ended last year – although the agency recognizes the importance of interchangeability and is trying to expedite the process.
Read about the meeting and presentations made earlier this month in D.C. in a report from the Center for Biosimilars.