Accord Backed In EU For Trastuzumab And Apixaban

Part Of May Meeting of EMA’s CHMP

Accord Healthcare is looking to breaking into the crowded market for biosimilar trastuzumab in the EU, after partner Henlius’ application was backed by the EMA’s CHMP. Meanwhile, a recommendation for a generic to the Eliquis anticoagulant was also forthcoming from the committee.

Green_Light
Accord's applications for biosimilar trastuzumab and generic apixaban have been greenlit • Source: Shutterstock

Accord Healthcare scooped two recommendations for pan-European marketing authorization approvals following the May meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use, including the Zercepac (trastuzumab) biosimilar in-licensed from Chinese player Shanghai Henlius Biotech.

More from Biosimilars

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.