Biosimilars Articles
Celltrion’s Avtozma (tocilizumabanoh), a biosimilar to Actemra (tocilizumab), in both intravenous (IV)and subcutaneous (SC) formulations, has been approved by the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration has approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), to treat multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis.
FDA has approved Alvotech’s Simlandi (adalimumab-ryvk) as the third interchangeable Humira biosimilar.
The U.S. Food and Drug Administration (FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara for adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn's disease; and moderately to severely active ulcerative colitis.
The U.S. Food and Drug Administration has approved Samsung Bioepis; Halima (adalimumab-bwwd) for the treatment of several autoimmune disorders, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn's disease.
Amgen’s biosimilar to Johnson & Johnson’s rheumatoid arthritis drug, Remicade, has been approved by the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration (FDA) has approved Ziextenzo (pegfilgrastim-bmez), the 24th biosimilar approval in the U.S.
Pfizer’s Nivestym (filgrastim-aafi) has been approved by FDA for all eligible indications of the reference product.
