The FDA, which had already criticized the plant where Biocon is producing biosimilars for the U.S. market, has now issued it and partner Mylan a complete response letter tied to manufacturing for one of them.
The Indian company said on Tuesday that the FDA had issued the CRL for their proposed biosimilar pegfilgrastim, a copy of Amgen’s chemotherapy companion drug Neulasta.
It is another piece of bad news for Biocon and Mylan, which are having trouble getting their biosimilars approved. It is, however, a big break for Amgen, which is facing a barrage of biosimilar attacks on its aging portfolio of top-selling drugs. Last summer the FDA issued Novartis a CRL for the copy of Neulasta that its Sandoz unit had developed. Neulasta netted $4.72 billion in sales last year, with $3.89 billion of that coming in the U.S.
Biocon today said the CRL didn’t raise questions about the safety or biosimilarity of its drug but relates to an update on “facility requalification activities post recent plant modifications.” It said it would work quickly with the FDA to resolve the issues and that it didn’t expect a delay in getting the biosimilar to market.
The company has been making changes in its CMC processes after the FDA this spring criticized the Bangalore plant in an eight-page, 10-observation Form 483. An inspection found problems across the entire range of processes, including in aseptic processing and filling, environmental monitoring, data recording, cleaning procedures and even in its processes for buying sterile gloves for employees.
European regulators also have raised questions about the plant, leading Biocon and Mylan to pull their applications there for the Neulasta biosimilar and and their biosim of Roche’s blockbuster cancer drug Herceptin (trastuzumab).
The partners also are seeking approval of a Herceptin copy in the U.S. and in July it won a unanimous FDA advisory committee recommendation for their candidate to treat HER2-positive breast cancer, both for patients after surgery and for metastatic disease. Then just ahead of its September PUDFA date, Biocon reported that the FDA had put off a decision on their application until December to have time to go over what Biocon called “clarificatory information.” Biocon insisted that none of the info being sought had anything to do with the manufacturing concerns and said it didn’t expect the delay to effect an anticipated launch of the copy in the U.S.