Aurobindo has submitted its first biosimilar application to the EMA, with the Indian company’s CuraTeQ subsidiary filing its BP14 pegfilgrastim rival to Neulasta.
Aurobindo has achieved a milestone for its biosimilars business by submitting its first biosimilar marketing authorization application to the European Medicines Agency.
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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 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.”
The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.
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.
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.
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.
Generics Bulletin previews the most noteworthy and anticipated events for May 2025.
