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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.
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.
Stable Patient Satisfaction Found After Switching From the Humira or Biosimilar CT-P17
December 14th 2024A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.
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.
Similar Persistence Rates Between Adalimumab New Starts, Switched Patients
December 7th 2024A French real-world study found that the adalimumab biosimilar SB5 was effective in treating rheumatic or gastrointestinal immune-mediated inflammatory diseases, showing no loss of disease control in switched patients and similar persistence rates between naive and switched groups.
Cost and Efficacy Insights on Infliximab Biosimilars in Pediatric Uveitis
December 3rd 2024The study highlights the safety, efficacy, and cost benefits of infliximab biosimilars in managing pediatric noninfectious uveitis, showing fewer disease flares and reduced costs compared with reference infliximab, as well as the influence of insurance mandates on treatment decisions.
