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Biosimilars

Set Alert for Biosimilars

Biosimilar Education And Innovation Bills Head To Biden’s Desk

The Advancing Education on Biosimilars Act and the Ensuring Innovation Act will be looked at by the US President Joe Biden, after receiving the approval of both the Senate and the House of Representatives. The bills are aimed at lowering prescription drug costs and saving overall healthcare costs. 

United States BioPharmaceutical

Amgen Tells Sandoz On Enbrel: You Lost On The Facts

Amgen has hit back at Sandoz’ petition for a writ of certiorari against a US Court of Appeals for the Federal Circuit decision that leaves the biosimilar sponsor unable to market its Enbrel biosimilar more than three decades after the biologic was first launched.

Biosimilars Intellectual Property

PlantForm Strikes Deal For Brazilian Pembrolizumab

Canada’s PlantForm has struck a deal with Brazil’s Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab rival to Merck’s Keytruda for the Brazilian market and potentially beyond.

Deals Biosimilars

Centus Settles US Litigation Over Avastin

Centus Biotherapeutics and Roche’s Genentech have agreed to settle US patent litigation over the biosimilars firm’s FKB238 proposed bevacizumab rival to Avastin.

Legal Issues Intellectual Property

Prestige And Pharmapark Add Bevacizumab To Russia Collaboration

Russia’s Pharmapark has added Prestige BioPharma’s HD204 biosimilar bevacizumab product to the firms’ commercialization partnership, two years after kicking off the partnership with trastuzumab.

Biosimilars Deals

Biosimilars Bodies Urge Communication Enhancements For BsUFA III

Biosimilars industry stakeholders have suggested ways to enhance communication and improve the US regulatory pathway for biosimilars, as they weighed in on an interim assessment of the program for enhanced review transparency and communication in the Biosimilar User Fee Act II, ahead of the upcoming reauthorization of BsUFA for fiscal years 2023 through 2027 by the FDA. 

Biosimilars Regulation
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