Latest news with #PsoriaticArthritis
Associated Press
02-06-2025
- Business
- Associated Press
Access Barriers Hamper Early Line Adoption of UCB's Bimzelx at Six Months Post-Launch in Psoriatic Arthritis and Axial Spondyloarthritis, According to Spherix Global Insights
EXTON, PA, June 02, 2025 (GLOBE NEWSWIRE) -- Just over six months into its dual launch across Psoriatic Arthritis (PsA) and Axial Spondyloarthritis (axSpA), UCB's Bimzelx (bimekizumab) is demonstrating meaningful promise, though prescriber momentum remains tempered by access hurdles and payer-imposed constraints, according to new findings from Spherix Global Insights' Launch Dynamix™ services. Physicians across both PsA (n=76) and axSpA (n=73) have expressed strong clinical enthusiasm for Bimzelx, particularly citing its unique dual inhibition of IL-17A and IL-17F as a differentiator from existing IL-17 agents. In PsA, rheumatologists report confidence in the drug's performance across both skin and joint domains and consider it a therapeutic advance over competitors like Novartis' Cosentyx and Eli Lilly's Taltz. In axSpA, particularly among more severe or refractory patients, Bimzelx is increasingly viewed as a preferred IL-17, with some physicians already positioning it ahead of established options in terms of anticipated efficacy and breadth of benefit. Despite its favorable clinical profile, Bimzelx's adoption is constrained by a consistently challenging reimbursement environment. In PsA, nearly all prescriptions require prior authorization, with step therapy requirements and payer preferences for legacy agents continuing to block earlier use. These access challenges are echoed in AS and nr-axSpA, where physicians cite not only high out-of-pocket costs and Medicare limitations but also a general lack of formulary inclusion across plans. While some rheumatologists note success in early line use, many describe regular denials and delays that often force them to default to more accessible agents despite clinical preference for Bimzelx. As one rheumatologist summarizes, 'I like Bimzelx. The big headwind I'm facing now, it just gets denied by insurers. So commercial insurance coverage, which seems to always plague UCB products, is horrible. I'm hoping that will improve.' To address these access barriers, some physicians are turning to samples and bridge programs. However, in PsA, just 13% of patients initiated on Bimzelx started with a sample or free drug, with a pattern similarly observed in axSpA. While sampling and bridge programs are providing a critical means to initiate Bimzelx, physician sentiments support that these are often used to navigate around access hurdles, with uncertainty remaining around consistent conversion to insurance coverage and sustainability of this approach. While access barriers are a common thread, and also are common across many recently launched biologics in immunology, notable differences are emerging in how Bimzelx is being adopted and perceived across PsA versus axSpA. In PsA, two-thirds of rheumatologists have already prescribed Bimzelx, typically for patients with severe or flaring disease after failing multiple advanced therapies. Many express interest in moving the therapy earlier in the treatment algorithm but, again, remain limited by payer mandates. By contrast, adoption in axSpA is still ramping up, particularly in nr-axSpA, where just a minority of rheumatologists have used the product to date. Though uptake is slower, satisfaction levels remain high among those with prescribing experience, and many physicians expect to expand use as coverage improves. In addition to ramped trial and utilization, promotional efforts from UCB are beginning to resonate. The majority of rheumatologists report contact with Bimzelx sales representatives, who are largely praised for their professionalism and ability to communicate key efficacy and safety differentiators. However, a notable subset of physicians in both PsA and axSpA have yet to be detailed, and limited awareness of support services—such as the Bimzelx Navigate program—suggests more work is needed to fully activate the prescriber base. Those who have engaged with Navigate report a positive experience, citing timely support and ease of use, though these accounts remain limited. As the launches progress, the key question is whether UCB can convert strong clinical perceptions into real-world usage at earlier points in care. While Bimzelx is well-positioned from an efficacy standpoint, its long-term success will hinge on overcoming payer resistance and improving patient access. Spherix Global Insights will continue to track Bimzelx's PsA, AS and nr-AxSpA U.S. launch trajectory through its Launch Dynamix™ service through the first eighteen months of commercial availability. Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. Lynn Price, Rheumatology Franchise Head Spherix Global Insights 4848794284 [email protected]
Medscape
20-05-2025
- Health
- Medscape
Biologics, Targeted Therapies Best for Acute PsA Dactylitis
Biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) seemed to be the most effective treatments for patients with acute psoriatic arthritis (PsA) dactylitis. METHODOLOGY: In a prospective observational cohort, the median age of 1735 patients with PsA was 44.9 years, and 55% were men. During a median follow-up of 12.1 years, dactylitis occurred in 753 (43.4%) patients and the remaining 982 (56.6%) never had it. Among the patients with dactylitis, 295 (39.2%) were treated with nonsteroidal anti-inflammatory drugs (NSAIDs), 273 (36.3%) with conventional synthetic DMARDs, 100 (13.3%) with biologic or targeted synthetic DMARDs, 64 (8.5%) with glucocorticoid injection and a change in DMARD therapy, and 21 (2.8%) with glucocorticoid injection. TAKEAWAY: Univariable and multivariable analyses showed that the most significant clinical factors associated with acute PsA dactylitis included younger age, male sex, the presence of nail disease, a higher Clinical Disease Activity Index for Psoriatic Arthritis score and a higher modified Steinbrocker score for radiographic damage. The median time to resolution of acute symptoms was 0.8 months. Treatment with biologic or targeted synthetic DMARDs was associated with faster resolution of acute PsA dactylitis symptoms and longer time to recurrence than other therapies, including conventional synthetic DMARDs and NSAIDs. One third of patients experienced recurrence of acute PsA dactylitis following treatment, with a median time to recurrence of 2 years. IN PRACTICE: 'Acute dactylitis is common in about 43% of patients with psoriatic arthritis and considered a marker of disease severity, but we saw that treatment with biological or targeted DMARDS was associated with the best outcomes in terms of faster resolution of symptoms and prevention of recurrence,' Fadi Kharouf, MD, clinical research fellow at the University of Toronto/University Health Network, Toronto, Ontario, Canada, said in an interview. SOURCE: Kharouf presented the study at the Spondyloarthritis Research and Treatment Network (SPARTAN) 2025 Annual Meeting in Toronto, Ontario, Canada. LIMITATIONS: No limitations were reported. DISCLOSURES: The study was conducted as part of the Gladman Krembil Psoriatic Arthritis Program, which is supported by the Krembil Foundation and the Schroeder Arthritis Institute. Kharouf disclosed being supported by a fellowship from the Krembil Foundation.
Yahoo
10-02-2025
- Business
- Yahoo
Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2506, a Proposed Biosimilar to Simponi®, in the European Union
The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2506 as a biosimilar to reference product Simponi® The BAT2506 MAA is based on a robust analytical, non-clinical and clinical data package comparing BAT2506 to the reference product Simponi® GUANGZHOU, China, Feb. 7, 2025 /PRNewswire/ -- Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the EMA has accepted the MAA for BAT2506, a proposed biosimilar to Simponi® (golimumab), seeking a commercial license in the European Union(EU). The reference medicine golimumab has been approved in Europe for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. "The acceptance of the EMA MAA for BAT2506 marks another milestone for Bio-Thera as it is the first golimumab biosimilar developed by a Chinese company to be submitted to the EMA for approval," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. "Bio-Thera is committed to developing biosimilars for products like golimumab for patients around the world that are in need of affordable treatments." The MAA for BAT2506 is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of BAT2506 was conducted and supports biosimilarity to the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of BAT2506 with both, the EU and US, reference product in healthy volunteers, while a randomized, double-blind, multi-dose, two-arm, parallel group Phase 3 confirmatory study compared BAT2506 to the EU golimumab reference product to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Active Psoriatic Arthritis. Bio-Thera Solutions and STADA Arzneimittel AG entered into a commercialization and license agreement to develop, manufacture and commercialize BAT2506 on May 28th, 2024. Under the agreement, Bio-Thera Solutions maintains responsibility for development, manufacturing, and supply of BAT2506. STADA has exclusive regulatory and commercial rights to BAT2506 in the EU, the UK, Switzerland and select other countries. About BAT2506 (golimumab)BAT2506 is a proposed biosimilar to Simponi® which is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule. Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. The reference medicine golimumab has been approved in Europe for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. About Bio-Thera SolutionsBio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including four approved products: QLETLI® and BETAGRIN®(Bevifibatide Citrate Injection) in China, and TOFIDENCE®/ BAT1806 and Avzivi® / Pobevcy® in the US, EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera). Cautionary Note Regarding Forward-Looking StatementsThis news release contains certain forward-looking statements relating to BAT2506 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1. Simponi® is a registered trademark of Johnson & Johnson Corporation2. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.3. TOFIDENCE® is a registered trademark of Biogen International GMBH4. Avzivi® is a registered trademark of Sandoz AG5. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. Bio-Thera Solutions, Ltd. ContactBert E. Thomas IV +1.410.627.1734bethomas@ View original content to download multimedia: SOURCE Bio-Thera Solutions, Ltd Sign in to access your portfolio
