Dr Reddy’s Moves Ahead With Global Rituximab Filings

US FDA, EMA And MHRA Accept Firm’s Rituxan/MabThera Biosimilar Rival For Review

Dr Reddy’s has celebrated a “milestone” for its biosimilars business after disclosing that multiple regulators in Europe and the US have accepted its rituximab filings for review.

Dr Reddy's logo on website under magnifying glass
Dr Reddy’s has filed rituximab with multiple regulators • Source: Shutterstock

Dr Reddy’s is pushing forward with global registrations for its proposed biosimilar rival to Rituxan/MabThera (rituximab), announcing that multiple regulators – the US Food and Drug Administration, the European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency – have accepted the candidate for review, in a “milestone” for its biosimilars business.

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

More from Biosimilars

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By 

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Amgen’s Aflibercept Starts Strong As Regeneron Counts Cost Of Eylea Competition

 
• By 

Amgen told investors during its 1 May first-quarter earnings call that its Pavblu biosimilar to Eylea 2mg had flown out of the gates, while Regeneron admitted “some difficult news related to our retinal franchise.”

BGMA Becomes Medicines UK

 
• By 

The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By 

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

More from Products

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By 

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By 

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

What’s Next? Five Things To Look Out For In May

 
• By 

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.