Two Of Aurobindo’s Europe Biosimilar Filings Stuck, Licenses Ryzneuta From Yifan Pharma
Could MHRA Approve Bevacizumab Biosimilar Minus Phase III Trial?
Even as two biosimilar filings in Europe are stuck due to a lack of inspection staff and a biosimilar could be approved in the UK without a Phase III trial, Aurobindo has licensed novel drug Ryzneuta from Yifan Pharma. Meanwhile, a $650-700m revenue forecast for the specialty business has been pushed back as both overall revenues and profits declined during Q2.
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FDA’s observations at Aurobindo subsidiary Eugia's plant in India and a new one in New Jersey could lead to more drug shortages in the US, particularly injectables, though the company aims to streamline production by end-March. Meanwhile, it will capitalize on the “sizable opportunity” from the EU's list of critical medicines while launching a Herceptin biosimilar in India
Starting off with MSD as an anchor partner, Aurobindo plans to eventually spar with the likes of WuXi and Lonza while building scale for its biologics CDMO business. Meanwhile, EMA approval for a greenfield project in China and an US FDA nod for Ryzneuta, licensed from Yifan’s Evive Biotech, signal a boost
A US FDA tentative approval for Aurobindo’s dolutegravir combination generic for children should increase access under the PEPFAR program and aid sales. On a Q1 earnings call, renewed efforts to restructure Eugia, biosimilar launch plans and fallouts of oral drug shortages and damage to Pfizer’s US injectables warehouse were discussed.