Bad Miss For Biocon’s Bevacizumab In US But Firm In 'Good Place'
Indian Company Remains Upbeat As It Reports Full-Year Results
Biocon is still awaiting a site inspection as pandemic-related delays keep its Viatris-partnered bevacizumab out of the US market, though the Indian company believes it can still make good and garner market share. All eyes are also on traction for its insulin glargine via increased share of formulary contracts.
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Amgen’s biosimilars sales will almost certainly smash through the $2bn barrier in 2021, driven by the strength of its product portfolio including bevacizumab and trastuzumab. The California-based biotech has warned, however, that greater competition will naturally lead to pricing challenges.
Viatris and Biocon Biologics are now in a position to enter the European market for biosimilar bevacizumab, after the European Commission formally approved the pair’s Abevmy rival to Avastin.
Details of how the FDA plans to conduct remote evaluations of manufacturing facilities during the COVID-19 pandemic have been set out in guidance published by the US agency.