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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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Bad Miss For Biocon’s Bevacizumab In US But Firm In 'Good Place'

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.

Bad Miss For Biocon’s Bevacizumab In US But Firm In 'Good Place'

Biocon awaits site inspection after pandemic-amplified delays keep its Viatris-partnered bevacizumab out of the US market, though the Indian company believes they can still make good and garner market share. All eyes are also on traction for their insulin glargine via increased share of formulary contracts.

Former FDA Official Criticizes COVID-19 Guidance’s Silence On Biosimilars

Former senior FDA official Eva Temkin has criticized the FDA’s silence on the development of biosimilars and interchangeable products in its recent COVID-19 guidance, suggesting that the agency’s stance on 180-day exclusivity for small-molecule generics could be extended to interchangeability exclusivity for biosimilars, while also pointing out that key questions around generic exclusivity are left unanswered

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