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.

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 ...

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) ...

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 ...

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)--BioSim Pharmaceuticals, a technology driven company, looks to create over the next few years, a significant product pipeline of generic injectables in the US all while ...