Viatris biosimilar faces regulatory delay

 

• The FDA has delayed its decision on the marketing application for MYL-1402O, a proposed biosimilar by Viatris (NASDAQ:VTRS) and India’s Biocon for the cancer therapy, Avastin (bevacizumab).
• The regulator has cited the need for more time to inspect the manufacturing facility, a part of the standard review process.
• If approved MYL-1402O will be the third biosimilar to target the blockbuster cancer drug from Roche Holding AG (OTCQX:RHHBY), after Pfizer (NYSE:PFE) and Amgen (NASDAQ:AMGN) won FDA clearance for their Avstin-biosimilars Zirabev, and Mvasi in 2019 and 2017, respectively.
• Though an inspection of the manufacturing facility was required for the review process, “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 has said.
• https://seekingalpha.com/news/3648043-viatris-biosimilar-faces-regulatory-delay