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Biosimilar

All articles tagged with #biosimilar

health2 years ago•3 min saved

FDA Approves Amgen's Biosimilar for Multiple Inflammatory Diseases, Including Psoriasis

The FDA has approved Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Stelara (ustekinumab) for the treatment of multiple inflammatory diseases, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This approval provides additional safe and effective treatment options for patients managing these conditions and has the potential to increase access to medication at potentially lower costs. Wezlana has been shown to be highly similar to Stelara in terms of safety and effectiveness, and it may be substituted for the reference product without consulting the prescriber, similar to how generic drugs are substituted for brand name drugs.

via FDA.gov|

#biosimilar #fda #health

health2 years ago•4 min saved

FDA Approves Groundbreaking Biosimilar for Multiple Sclerosis Treatment

The FDA has approved Tyruko, the first biosimilar to Tysabri, for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko is also indicated for treating moderately to severely active Crohn's Disease. Biosimilars are highly similar to already approved biological products and offer additional treatment options for patients. The approval of Tyruko is based on evidence showing no clinically meaningful differences in safety and effectiveness compared to Tysabri. However, both medications carry a boxed warning about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain.

via FDA.gov|

#biosimilar #fda #health

healthcare2 years ago•1 min saved

Coherus and Mark Cuban team up to offer discounted biosimilar Humira

Coherus BioSciences plans to sell a biosimilar version of Humira at an 85% discount from AbbVie's price, and will work with Mark Cuban's generic drug company to make the medicine available directly to consumers for even less. The move has the potential to alter one of the most closely watched product rollouts by pharmaceutical companies in many years, as AbbVie is expected to face at least eight biosimilar rivals to Humira by the end of the year.

via STAT|