Viatris And Biocon’s US Bevacizumab Hit By Indefinite Delay
Potential Third Avastin Biosimilar Hit By COVID-19 Inspection Uncertainty
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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Biocon Knocked Back By FDA On Human Insulin
Biocon has seen its insulin-R application knocked back by the US FDA, with a complete response letter citing a need for more data as well as the need for remediation activities at its Bangalore facilities.
Biocon Gets FDA Observations At Key Biosimilars Facilities
Biocon has revealed that an FDA inspection of key biosimilars manufacturing facilities in Bengaluru and Malaysia in August has resulted in numerous Form 483 observations across three Biocon Biologics sites.
What’s Next? Five Things To Look Out For In August
A busy August brings patent expiries, biosimilar target action dates and the potential for a major change to biosimilar prescribing guidelines in Germany.