The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India. The agency listed 10 observations made during the agency’s inspection conducted during May and June of 2017.
The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India.
The FDA inspectors listed 10 observations made during the agency’s inspection conducted during May and June of 2017:
The extensive, 8-page report comes on heels of similarly critical assessment from the French National Agency for Medicines and Health Products Safety (ANSM), which noted 35 problems at the facility, 11 of which were deemed major deficiencies. The ANSM recommended to the European Medicines Agency that no batch of any of the 3 biosimilars addressed in its findings be supplied to the European marketplace, and that the marketing authorizations for the products be revoked until ANSM can verify that all of its recommendations have been implemented.
Biocon’s trastuzumab biosimilar, MYL-1401O, which the company developed in collaboration with Mylan, is among the drugs identified in ANSM’s report as being affected by the deficiencies. The FDA’s Oncologic Drugs Advisory Committee voted unanimously to recommend approval of MYL-1401O in its July 13, 2017 meeting, during which no mention of the facility’s issues was made. With regulatory action for MYL-1401O expected in September, the inspection report raises the question of whether approval of the drug could be delayed until Biocon takes corrective action in its facility.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.