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

Two of Aurobindo’s biosimilars filings in Europe are likely delayed due to a lack of inspectors to examine its manufacturing facilities. However, another biosimilar filed in the UK might get an approval without the need for a Phase III efficacy trial.

An established generics player, Aurobindo has been building its biosimilars and specialty business in recent years,

Given that these hold the potential to push it past India’s number one company Sun Pharmaceutical Industries, analysts keenly watch biologics-related

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