Viatris’ Avastin biosimilar faces delay

The Food and Drug Administration has informed Biocon Biologics and Mylan, a subsidiary of Viatris of a deferred action on the biologics license application for MYL-14020, a biosimilar to Roche's Avastin (bevacizumab).

The medication is used to treat various types of cancers.

"To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the standard review process. However, due to restrictions on travel related to Covid-19, the agency is unable to conduct an inspection during the current review cycle. We await the dates for the inspection," Biocon said in a regulatory filing.

If approved, MYL-1402O will be the third biosimilar to Avastin. Pfizer and Amgen obtained the FDA's clearance for their Avastin-biosimilars Zirabev, and Mvasi in 2019 and 2017, respectively.