No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.
No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.
Drug maker UCB announced this month that a phase 3 active-controlled trial of its investigational bispecific antibody, bimekizumab, which targets interleukin 17A and 17F, showed superiority to adalimumab (Humira) in treating psoriasis.
The study, BE SURE, enrolled 480 patients with chronic plaque psoriasis who received either 1 of 2 possible dosing regimens of bimekizumab or received adalimumab. The coprimary endpoints of the study were 90% improvement in Psoriasis Area and Severity Index (PASI) score and investigator global assessment (IGA) response of clear or almost clear skin.
The drug met the primary endpoints at week 16, says UCB, as well as its ranked secondary endpoints, including superior total skin clearance versus adalimumab at weeks 16 and 24 as measured by PASI 100. Patients also had a faster response to the bispecific antibody than they did to adalimumab.
The safety and efficacy of bimekizumab are also being evaluated in patients with other inflammatory diseases, including psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Top-line results are anticipated by the end of 2021.
The drug also outperformed ustekinumab (Stelara) in another phase 3 study, BE VIVID, a 52-week trial in patients with psoriasis. In that study, bimekizumab met the co-primary endpoints of PASI90 and IGA score of clear or almost clear, demonstrating greater efficacy versus both placebo and ustekinumab.
Additionally, in the BE ABLE study, also in patients with psoriasis, 79% of patients treated with the bispecific achieved at least PASI90 at week 12, significantly outperforming placebo.
These results come as some experts warn that, by the time that biosimilars of adalimumab become available, patients will have moved on to more effective therapies and will be unwilling to opt for the older adalimumab, and that the biosimilar options may have less of an impact on the high-cost market for biologics in the United States than had previously been hoped.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.