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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Industry stakeholders have offered their views on key priorities for the BsUFA biosimilars user-fee program ahead of its reauthorization.
Biocon has secured the latest in a series of investments in its Biocon Biologics subsidiary, from Abu Dhabi based ADQ. The transaction, worth around $75m, values the biosimilars unit at $4.17bn.
Amgen has filed to settle on undisclosed terms patent-infringement litigation involving both its Kanjinti and Mvasi biosimilars, having previously seen originator Genentech fail multiple times to block commercial sales of the products that were launched ‘at risk’.