Biosim makers scored a big win Monday as the Supreme Court ruled with Sandoz in a much-watched legal dispute against Amgen. The landmark decision, set to leave a distinct mark on the budding field, ...
Regulators on both sides of the Atlantic have agreed to review Novartis’ approval bid for a biosimilar to Biogen’s Tysabri. The potential green light could spell trouble for the multiple sclerosis ...
SEATTLE--(BUSINESS WIRE)--BioSim Pharmaceuticals, Inc. today announced that it has selected CPC Scientific to supply BioSim with their cGMP ACTH peptide. BioSim’s ACTH Gelatin Depot 80 IU/mL product ...
Though Celltrion appears to be delaying the start of late-stage trials for its biosim version of Rituxan, BioPharm reports that the company should be considered in third place in the race to advance ...
SEATTLE--(BUSINESS WIRE)--Held annually alongside Biotech Showcase and OneMed Forum, the JP Morgan conference is one of the largest and most informative healthcare symposiums in the industry. BioSim ...
FDA rejects Novartis’ biosim app for Amgen blockbuster By Ben Adams Jul 19, 2016 4:17am chemotherapy Amgen Complete Response Letter Food and Drug Administration (FDA) ...
The Biosimilars Council, representing leading developers of biosimilar medicines, strongly supports the reintroduction, and encourages swift passage, of the bipartisan BIOSIM Act (HR 2815). "The ...
Twenty-eight patient advocacy groups wrote a letter pledging endorsement of the Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act, a bill aimed at increasing reimbursement ...