Two Of Aurobindo’s Europe Biosimilar Filings Stuck

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 $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,

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Biosimilars

More from Products