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Viatris And Biocon’s US Bevacizumab Hit By Indefinite Delay

Potential Third Avastin Biosimilar Hit By COVID-19 Inspection Uncertainty

 
• By Dave Wallace

Viatris and partner Biocon have seen FDA action on their application for a bevacizumab biosimilar rival to Avastin delayed by the need for a facility inspection, the timing of which is uncertain due to coronavirus-related restrictions.

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Viatris’ bevacizumab application has been indefinitely delayed • Source: Shutterstock

Viatris will not see US Food and Drug Administration action on its application for a bevacizumab proposed biosimilar to Avastin by the end of 2020 as anticipated, after the agency said it would need to conduct an inspection of the manufacturing facilities of the firm’s development partner, India’s Biocon.

Early this year, Mylan – ahead of its merger with Pfizer’s Upjohn to become Viatris – had revealed an FDA goal date of 27 December 2020 for the MYL-1402O bevacizumab candidate

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