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Two Of Aurobindo’s Europe Biosimilar Filings Stuck, Licenses Ryzneuta From Yifan Pharma

Could MHRA Approve Bevacizumab Biosimilar Minus Phase III Trial?

 
• By Vibha Ravi

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

Two of Aurobindo Pharma Limited’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,

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