New Biosimilar Autoimmune Disease Treatment Approved by FDA
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.
FDA Approves Epysqli, Second Biosimilar to Soliris
Samsung Bioepis’ biologics license application for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab) has been approved by the U.S. Food and Drug Administration (FDA) to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
Fresenius Kabi’s Tyenne, a Biosimilar of Actemra, Is Approved to Treat Autoimmune Diseases
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.
Third Humira Biosimilar Is Approved by FDA
FDA has approved Alvotech’s Simlandi (adalimumab-ryvk) as the third interchangeable Humira biosimilar.
FDA Approves Wezlana, First Interchangeable Biosimilar to Stelara
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.
FDA Approves Biosimilar to ACTMRA
The U.S. Food and Drug Administration has approved Biogen’s tocilizumab-bavi (TOFIDENCE), a biosimilar option referencing ACTMRA, to treat moderately to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (JIA).
Biosimilars and the Fight Against Inflation
New legislation promised to increase patient access to critical drug products by lower costs. Will it work?
FDA Approves Humira Biosimilar to Treat Autoimmune Disorders
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.
FDA Approves Biosimilar to Rheumatoid Arthritis Drug
Amgen’s biosimilar to Johnson & Johnson’s rheumatoid arthritis drug, Remicade, has been approved by the U.S. Food and Drug Administration.
FDA Approves Sandoz’s Ziextenzo as 24th Biosimilar
The U.S. Food and Drug Administration (FDA) has approved Ziextenzo (pegfilgrastim-bmez), the 24th biosimilar approval in the U.S.
