Two Of Aurobindo’s Europe Biosimilar Filings Stuck

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 $650m-$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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