1. Generics Bulletin
  2. >>Products
  3. >>Biosimilars

Mylan's Aflibercept Biosimilar Gets Green Light For Trials In India

 
• By Anju Ghangurde

Mylan’s proposal to progress studies for its aflibercept biosimilar has been endorsed by an expert panel in India, which expects availability of such biosimilars to expand access to anti-VEGF therapies.

Green
Mylan's Biosimlar Rival To Eylea Gets Go Ahead For Phase III • Source: Shutterstock

Mylan NV has received the go ahead in India to progress studies for its proposed biosimilar to Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) injection, that is being developed under a collaboration with Momenta Pharmaceuticals Inc.

A subject expert committee (SEC), a key panel which advises the Indian drug regulator on trial-related approvals, recently recommended that MYL-1701P, Mylan’s proposed biosimilar rival to Eylea be granted permission for Phase III trials in India; the product entered Phase

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

Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

 
• By Dave Wallace

During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

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 Dean Rudge

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 Dave Wallace

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

More from Products

BGMA Becomes Medicines UK

 
• By Dave Wallace

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 Dave Wallace

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 Dean Rudge

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.