Eye on Pharma: FDA Delays Decision on Biocon's Trastuzumab Until December

Biocon announced today in a letter to the National Stock Exchange of India that the FDA has extended its target action date for a regulatory decision on the drug maker’s trastuzumab biosimilar.

A company spokesperson said that the FDA “has notified our partner Mylan that they will extend the target action date for their [trastuzumab] 351(k) application to December 3, 2017 in order to review some of the clarificatory information submitted to them as part of the application review process. This [3-]month extension has no impact on the anticipated timetable for commercialization of this product in the [United States].”

A regulatory decision on the Indian drug maker’s biosimilar, MYL-1401O (referenced on Genentech’s Herceptin), had been expected on or before its Biosimilar User Fee Act date of September 3, 2017. The drug received a unanimous recommendation of approval from the FDA’s Oncologic Drugs Advisory Committee (ODAC) in July.

However, the drug has faced regulatory challenges in the European Union; earlier this month, Biocon withdrew its filings for both its trastuzumab product and its pegfilgrastim candidate from the European Medicines Agency (EMA). Biocon indicated that it would resubmit its applications to the EMA after regulators complete a re-inspection of its manufacturing facility in Bangalore. The re-inspection is required after France’s health regulatory body, the French National Agency for Medicines and Health Products Safety (ANSM), found that Biocon had failed to comply with good manufacturing practices in the production of 3 biosimilar products (including trastuzumab). ANSM identified 35 problems related to drug product manufacturing and quality control operations, and called 11 of those problems “major deficiencies.”

It is unclear whether the FDA’s delay of a decision on Biocon’s trastuzumab is related to the deficiencies in good manufacturing practices identified by ANSM or to the re-inspection of the facility. However, the FDA and the EMA recently signed a new confidentiality agreement allowing the agencies to share full inspection reports, including nonpublic, commercially confidential information related to inspections.