Hadlima, Biosimilar to Humira, Receives FDA Approval to Treat Autoimmune Diseases

Hadlima, Biosimilar to Humira, Receives FDA Approval to Treat Autoimmune Diseases
Hadlima (adalimumab-bwwd) — an antibody biosimilar to AbbVie's Humira (adalimumab) — has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of a number of autoimmune diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, ulcerative colitis, and adult Crohn's disease. Biosimilars are to biologic medicines (which are made using living cells, rather than by chemical synthesis) as generics are to traditional medications. Biosimilars are an alternative that can introduce competition into the market, and are designed to work in the same way as biologic medicines. In this case, Hadlima, like its reference therapy, works by blocking the signaling protein tumor necrosis factor (TNF) alpha and prevents its pro-inflammatory effects. Hadlima is the third anti-TNF biosimilar made by Samsung Bioepis to be approved in the United States; the others are Renflexis (infliximab-abda) and Eticovo (etanercept-ykro). Hadlima will be commercialized by Merck (MSD outside the U.S. and Canada). Because of a licensing agreement with AbbVie, the U.S. launch of the biosimilar is not expected until after June 30, 2023. "We believe the U.S. healthcare system can benefit from biosimilars, as they could play an impor
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