ARTICLE | Politics & Policy

Four biosimilar BLAs in limbo

September 18, 2015 12:55 AM UTC

Director Janet Woodcock of FDA's Center for Drug Evaluation and Research (CDER) shed new light on the biosimilars development pipeline during her congressional testimony on Thursday, but was not asked and did not volunteer information about four pending biosimilars applications that have passed or are near their user fee action dates.

Woodcock told the Senate Health, Education, Labor and Pensions (HELP) committee that as of July 31, 57 proposed biosimilars to 16 different reference products were enrolled in FDA's Biosimilar Product Development (BPD) Program. Her P13 from Celltrion Inc. (KOSDAQ:068270), a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). The user fee goal for a decision on the BLA was June 8. Celltrion has not provided information about the status of the BLA. ...