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.