FDA: holding meetings, but no biosimilar applications yet

FDA told BioCentury the agency has not received any applications for biosimilars under the 351(k) pathway, which was signed into law in 2010 as part of the Patient Protection and Affordability Act. As of Dec. 10, FDA said it has received 50 requests from sponsors for meetings for 12 reference products and has held 34 meetings to discuss proposed biosimilar product development programs.

A spokesperson for the agency's Center for Drug Evaluation and Research said some meetings have been cancelled "because it is premature to hold a meeting based on the stage of development" and/or because the company's meeting package "does not contain sufficient or adequate data or information for FDA to provide advice." The agency did not disclose how many meetings have been cancelled. The agency said it has received 12 IND applications for biosimilar development programs. ...