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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.
A Banner Year for Biosimilars: The 19 FDA Approvals From 2024
January 21st 2025In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Functional Similarity Between Ustekinumab Biosimilar ABP 654, Stelara in Crohn Disease
January 18th 2025Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.
