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Competition Strengthens for Humira Market With Approval of Second Biosimilar
The approval for adalimumab-adbm comes a year after the first adalimumab biosimilar, by Amgen, was approved in September of 2016.
The FDA has approved the tumor necrosis factor (TNF) inhibitor adalimumab-adbm (Cyltezo) injection for subcutaneous use in patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis.
Developed by Boehringer Ingelheim (BI), this is the second adalimumab (Humira, Abbvie) biosimilar to be approved in the United States, nearly a year after adalimumab-atto (Amjevita, Amgen) was approved by the FDA in September 2016.
The most serious adverse events with adalimumab-adbm include infections and malignancies. The FDA has included a serious boxed warning for serious and sometimes fatal infections, including tuberculosis, bacterial sepsis, invasive fungal infections, and infections from other opportunistic pathogens. TNF blockers also increase the risk of lymphomas and other malignancies, particularly in young children and adolescents, according to the product label.
Abbvie, which has a multi-billion dollar market for the reference product, had filed a complaint against BI in a Delaware federal court earlier this month claiming that BI will infringe on 74 of its patents for adalimumab in its development of this product.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Eye on Pharma: Keytruda Biosimilar Deal; German Court Bans Imraldi; New Biosimilars for Japan
June 17th 2025Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans Humira biosimilar over patent dispute, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Infliximab Biosimilar Switch Due to Flare Risk: Monitoring Patients Is Crucial for Pharmacists
June 5th 2025Switching from reference infliximab to biosimilars (infliximab-abda and infliximab-dyyb) for rheumatic diseases may lead to treatment delays and a higher risk of disease flares, particularly when the switch is mandated by insurance.
