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.

Regulatory Affairs
Aurobindo's Biosimilar Filings In Europe See Regulatory Delay • Source: Shutterstock

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