The RPM Report: Has the agency received any biosimilar applications yet under the 351(k) pathway?
John Jenkins: The answer I’m supposed to give is that we haven’t approved any applications under the 351(k) biosimilar pathway....
Biosimilars in 2014: An Interview With FDA New Drugs Head John Jenkins
In addition to John Jenkins’ role as FDA’s top new drug review manager, he serves as head of the Biosimilars Review Committee—the internal panel tasked with grappling with actual application review issues for the abbreviated 351(k) program. The RPM Report spoke with Jenkins during the FDA/CMS Summit for Biopharmaceutical Executives in December. Here is an edited transcript of the conversation.