Biosimilar

The FDA approved Celltrion’s omalizumab biosimilar, Omlyclo, for the treatment of multiple conditions including asthma and food allergy, according to an agency press release.

The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, according to a press release from Celltrion.

Four biosimilars for Stelara have launched in the United States this year following legal settlements with the reference product manufacturer, Janssen Pharmaceuticals, which set timelines for their market entries.

Prior authorization reforms, increased biosimilar access and the future of the Medicare drug price negotiation program are among the American College of Rheumatology’s top concerns in a letter recently submitted to CMS.

The FDA has approved the first rapid-acting biosimilar insulin product for glycemic control in people with diabetes.

The FDA has approved a third biosimilar for tocilizumab, called Avtozma, the second such biosimilar to be available in both intravenous and subcutaneous formulations, according to a press release.

Money talks. And in the world of medicine, what it has to say has important implications for patients and providers alike.

The expansion of safe and effective FDA-approved biosimilars for inflammatory bowel disease set to launch in early 2025 may improve access to care, with the potential to reduce health care costs and revolutionize the treatment landscape.

The FDA has approved the Stelara biosimilar Steqeyma for the treatment of adults and children with plaque psoriasis and psoriatic arthritis and adults with Crohn’s disease and ulcerative colitis, Celltrion announced in a press release.

WASHINGTON — In this video, Micaela F. Bayard, MD, highlights a conversation on the evolution of biosimilars from ACR Convergence 2024.