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Viatris And Biocon’s US Bevacizumab Hit By Indefinite Delay

Potential Third Avastin Biosimilar Hit By COVID-19 Inspection Uncertainty

Executive Summary

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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As CEO Michael Goettler provides an update on the progress made by Viatris in its first year as a combined company, he also offers Generics Bulletin hints as to the detailed strategy that will be unveiled at the firm’s upcoming investor day and explains how biosimilars – including interchangeable Semglee (insulin glargine) – and complex generics are important components of the firm’s future growth plans.

FDA Will Take Action On Biosimilars Delayed By Inspection Lag

With multiple US biosimilar applications held up by the FDA’s inability to conduct necessary inspections in the context of the COVID-19 pandemic, the agency tells Generics Bulletin that it is “actively working” on a solution.

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