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 ...

Johnson & Johnson has kept a positive attitude about its blockbuster immunology drug Remicade and the biosimilar competition it’s facing. That optimism just got tougher to maintain—and believe.

But for the first time, Novartis has said in its second-quarter update that the FDA rejected its biosim application for the drug, which was accepted by the regulator last November. The review was ...

Samsung Bioepis races rivals as EMA accepts Herceptin biosim app By Ben Adams Oct 4, 2016 3:59am biosimilars breast cancer Biogen Herceptin ...

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 ...

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 ...

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 ...

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 ...