Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OS ...

Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe ...

We think Biogen's neurology, immunology, and focus on rare diseases support a narrow moat. Biogen's strategy has its roots in the 2003 merger of Biogen (Avonex for treating multiple sclerosis, or MS) ...

The Department of Veterans Affairs (VA) saved $67 million in 2023 through its strong adoption of biosimilars to curb the high ...

After a phase 3 study showed a promising pCR rate with HLX11, the pertuzumab biosimilar’s BLA has been accepted for review by the FDA.

Cancer Prevention Research publishes articles that focus on cancer prevention, preclinical, clinical, and translational research, with special attention given to molecular discoveries and an emphasis ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European ...

Shanghai Henlius Biotech, Inc. (“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for ...

Dr Reddy's Laboratories has partnered with Shanghai Henlius Biotech to develop and commercialize HLX15, a biosimilar to the cancer drug Darzalex. Henlius will manage development and manufacturing, ...

Dr Reddy’s Laboratories has signed a license deal with Shanghai Henlius Biotech to develop and market HLX15, an investigational cancer drug. Henlius will handle development and manufacturing, ...

After recent launches of biosimilar versions of Eylea and Stelara, Amgen projects its biosimilar sales will reach $4 billion ...