Biocon's proposed Avastin biosim hit with FDA rejection after failed plant inspection

Biocon’s recent biosimilar track record at the FDA isn’t looking so hot.

Following an insulin copycat slap-down last month, Biocon on Sunday revealed (PDF) a complete response letter from the FDA on a proposed biosim to Roche's Avastin.

Without divulging much detail, the company said the letter puts it on the hook to resolve “observations made during the facility inspection conducted in August, 2022,” which suggests a faulty manufacturing inspection is at least partly to blame for the rejection.

Biocon has been partnered on the program with Viatris, which recently sold its biosimilar business to Biocon for $3.3 billion. While that sale closed in November, Biocon and Viatris’ “business plans continue,” a Biocon spokesperson explained over email, noting that the Viatris team “continues to provide services” under the companies’ agreement.

The FDA snub comes right on the heels of a rejection for Biocon’s biosimilar version of insulin aspart in January. That rejection letter cited the need for additional data and corrective measures at manufacturing plants in Bengaluru, India.

It would seem the same FDA investigation is to blame for the Avastin biosim rebuke, too, given the timing of the inspection cited in Biocon’s latest filing.

Last August, FDA officials conducted on-site inspections of two Biocon production plants in Bengaluru and one facility in Johor, Malaysia. Inspectors cited 11 observations at each of the sites in India and six observations at the Malaysian plant.

These days, Biocon is flying solo on the biosimilar front. Last February, a subsidiary of the company said it would buy Viatris’ biosimilars franchise for up to $3.335 billion in a cash-and-stock deal. The transaction closed in late November. 

Editor's note: This story was updated on Feb. 14 with comments from Biocon.