Tony Hagen is senior managing editor for The Center for Biosimilars®.
MYL-14020 could have been the fourth US biosimilar approved by the end of 2020, but the FDA hasn't been able to complete a necessary foreign inspection, owing to the pandemic.
For Bengaluru, Karnataka, India–based Biocon Biologics, the pandemic has interrupted the FDA review process for its planned bevacizumab biosimilar.
Biocon has been informed by the FDA that a decision on its biologics license application (BLA) for the bevacizumab biosimilar candidate MYL-14020, referencing Avastin, has been deferred while the agency awaits an opportunity to inspect the company’s manufacturing facility.
Biocon announced in March 2020 that the FDA had accepted its BLA for MYL-14020. The anticipated decision date at the time was December 27, 2020. A European application for approval also has been filed, but Biocon did not provide an update on that progress.
Biocon is developing MYL-14020 for marketing in conjunction with Viatris, which was formed through the recent merger of Mylan and the Upjohn division of Pfizer.
“To complete the application, the [FDA] noted that an inspection of the manufacturing facility is required as a part of the standard review process,” Biocon said in an investors statement. “However, due to restrictions on travel related to [coronavirus disease 2019], the agency is unable to conduct an inspection during the current review cycle.”
Biocon said it would await an opportunity for an inspection from the FDA. The agency in March 2020 suspended most inspections outside the United States. “We are aware of how this action may impact other FDA responsibilities, including product application reviews,” the FDA said at the time.
The agency said it would consider “mission-critical” inspections on a case-by-case basis, rely more heavily on border inspections of incoming products, and place some trust in companies with a history of positive compliance. Some sharing of information and cooperation with foreign governments was incorporated into the strategy.
Mylan prior to the Upjohn merger had 20 biosimilars and insulins in its portfolio of marketed and pipeline products. Upjohn was spun off from Pfizer, which retained its biosimilar portfolio. Mylan and Biocon have jointly distributed trastuzumab (Ogivri) and pegfilgrastim (Fulphila) biosimilars. They are also working to obtain biosimilar status for the insulin glargine product Semglee, which was approved in the United States in June 2020.