Problematic facility inspection puts Biocon’s biosimilar EU approvals on hold
Indian firm Biocon has been hit by regulator criticism which has forced its European biosimilar programme on hold following a March inspection which identified 35 deficiencies at the company’s production plant in Bengaluru, India.
Operating on behalf of the EMA, the French National Agency for Medicines and Health Products Safety conducted pre-approval inspections for Biocon’s biosimilar versions of Roche and Genentech’s cancer treatment Herceptin (trastuzumab) and Amgen’s Neulasta (pegfilgrastim), a drug designed to protect against infection during chemotherapy. The inspection also covered Biocon’s production of insulin glargine.
Of the 35 deficiencies, 11 were considered major, including but not limited to environmental monitoring and training, cleaning and process validation, batch manufacturing records and cross contamination risks. Biocon did not reveal the specific nature of the observations, but noted that none were deemed critical. However, until the recommended corrective and preventative actions have been carried out at the facility, the company will not see approval for its biosimilar products.
The firm made it known that it plans to correct the issues as soon as it can, noting: “Biocon, along with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow-up inspection of the drug product facility and the marketing authorisation applications with the goal of an early re-inspection.”
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