Sanofi should be granted a pan-European marketing authorization for its biosimilar version of NovoRapid (insulin aspart), the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended.
Sanofi’s Insulin Aspart Biosimilar Gets European Nod
As Accord’s Cabazitaxel And Fingolimod Are Endorsed By CHMP
Sanofi has received a positive opinion from the CHMP for its insulin aspart biosimilar rival to NovoRapid. Meanwhile, Accord and Janssen-Cilag have also received positive opinions for generics and hybrid medicines.
More from Biosimilars
• 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.
• 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.”
• By
The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.
• 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
• 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.
• 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.
• By
Generics Bulletin previews the most noteworthy and anticipated events for May 2025.