Biosimilars Rheumatology Roundup: June 2025

Recent developments in rheumatology highlight progress in biosimilar access and use, including FDA approval of a pediatric indication for Steqeyma, setbacks and partnerships affecting adalimumab biosimilars in global markets, real-world insights into patient switching patterns, and new clinical data supporting the safety, efficacy, and usability of biosimilars like CT-P47 for rheumatoid arthritis.

News for the Rheumatology Space

Celltrion announced that the FDA approved a new 45 mg/0.5 mL single-dose vial formulation of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), expanding dosing options for pediatric patients aged 6 to 17 years with plaque psoriasis or psoriatic arthritis who weigh less than 60 kg.1

The approval enhances dosing precision for a vulnerable population with variable weight-based needs, complementing previously approved formulations for both adult and pediatric use. With full interchangeability status across all Stelara indications, Steqeyma’s expanded offerings support improved access, treatment flexibility, and cost-effective care.

In recent business news, Samsung Bioepis faced a significant legal setback in Germany as the Düsseldorf Higher Regional Court ruled that its adalimumab biosimilar, Imraldi, infringed on a formulation patent held by Fresenius Kabi.2 The decision bans Imraldi sales in Germany, mandates a product recall, and imposes financial penalties, threatening broader disruptions across the European Union, where the patent remains valid.

Meanwhile, Samsung Bioepis announced a new strategic partnership with NIPRO Corporation in Japan to codevelop and commercialize biosimilars, including an ustekinumab candidate (SB17).

Real-World and Switching Data on Adalimumab Biosimilars

A recent Truveta analysis found that 13.2% of patients who switched from Humira to an adalimumab biosimilar ultimately returned to the originator, with nearly 40% of these switchbacks occurring within 30 days.3 While this trend may raise concerns about biosimilar efficacy, experts caution that factors like patient perception, limited biosimilar awareness, and the nocebo effect—rather than product failure—are likely driving these reversals. Older adults, women, and rural patients were more prone to switch back, highlighting the need for targeted education and support. The report also underscores the importance of ongoing evaluation of US interchangeability policies, especially as biosimilar adoption grows in response to formulary changes by major pharmacy benefit managers.

In other adalimumab data news, a study published in Advances in Therapy provided the pivotal evidence behind the FDA’s decision to grant Hulio (adalimumab-fkjp) interchangeable status with Humira (reference adalimumab).4 In a randomized trial of patients with moderate to severe plaque psoriasis, those who underwent multiple switches between Hulio and the reference biologic showed no differences in pharmacokinetics, safety, efficacy, or immunogenicity compared to those who remained on Humira. These findings fulfill FDA requirements for interchangeability and support pharmacist-level substitution without prescriber approval, which can boost biosimilar uptake, reduce costs, and expand access. Hulio’s designation marks a key milestone in advancing biosimilar integration into US health care.

Real-world data from a large cross-sectional survey across five European countries highlights the strong performance of the adalimumab biosimilar ABP 501 (Amgevita/Amjevita) in treating immune-mediated inflammatory diseases (IMIDs).5 The study, which included 1,296 patients either initiating therapy or switching from Humira, found high satisfaction rates among both physicians and patients, with over 89% of physicians and 86% of patients reporting positive experiences. Patients showed improved disease control, reduced pain, and minimal impact on daily life. Even among those who switched for nonclinical reasons—such as cost or formulary changes—treatment effectiveness and quality of life remained consistent. The authors said their findings support the broader adoption of biosimilars like ABP 501 as a cost-effective and clinically sound option in managed care.

Other Trial Results

In other news on tumor necrosis factor agents, a pilot study published in the Journal of Pharmacy Technology found that nearly half of patients with rheumatic diseases who were nonmedically switched from reference infliximab to biosimilars (infliximab-abda or infliximab-dyyb) experienced flares or loss of disease control, with most events occurring within 4 months of the switch.6 Delays in treatment—often due to insurance-mandated switching and prior authorization hurdles—may have contributed to these outcomes. While the small sample size and limited biosimilar availability constrain broader conclusions, the findings underscore the importance of pharmacist involvement in monitoring and educating patients during biosimilar transitions.

Patients with moderate to severe rheumatoid arthritis were able to safely and effectively self-administer the tocilizumab biosimilar CT-P47 using an autoinjector, highlighting the growing role of biosimilars in expanding access and reducing treatment costs. After 12 weeks, participants showed significant improvements in disease activity and reported high satisfaction and ease of use, with no autoinjector malfunctions and mostly mild to moderate adverse events. These results align with prior data on intravenous CT-P47 and reinforce the potential of subcutaneous biosimilar options to support patient independence and alleviate the economic burden of chronic inflammatory diseases.

References

1. Jeremias S. FDA approves Steqeyma for children with plaque psoriasis, psoriatic arthritis. The Center for Biosimilars®. June 17, 2025. Accessed July 1, 2025. https://www.centerforbiosimilars.com/view/fda-approves-steqeyma-for-children-with-plaque-psoriasis-psoriatic-arthritis

2. Jeremias S. Eye on pharma: Keytruda biosimilar deal; German court bans Imraldi; new biosimilars for Japan. The Center for Biosimilars. June 17, 2025. Accessed July 1, 2025. https://www.centerforbiosimilars.com/view/eye-on-pharma-keytruda-biosimilar-deal-german-court-bans-imraldi-new-biosimilars-for-japan

3. Jeremias S. adalimumab double take: the unexpected return to reference Humira. The Center for Biosimilars. June 30, 2025. Accessed July 1, 2025. https://www.centerforbiosimilars.com/view/adalimumab-double-take-the-unexpected-return-to-reference-humira

4. Jeremias S. New data support Hulio as an interchangeable adalimumab option. The Center for Biosimilars. June 16, 2025. Accessed July 1, 2025. https://www.centerforbiosimilars.com/view/new-data-supports-hulio-as-an-interchangeable-adalimumab-option

5. Santoro C. Infliximab biosimilar switch due to flare risk: monitoring patients is crucial for pharmacists. The Center for Biosimilars. June 5, 2025. Accessed July 1, 2025. https://www.centerforbiosimilars.com/view/infliximab-biosimilar-switch-due-to-flare-risk-monitoring-patients-is-crucial-for-pharmacists

6. Jeremias S. European data confirm real-world benefits of adalimumab biosimilars. The Center for Biosimilars. June 11, 2025. Accessed July 1, 2025. https://www.centerforbiosimilars.com/view/european-data-confirms-real-world-benefits-of-adalimumab-biosimilars

7. Santoro C. Tocilizumab biosimilar CT-P47 shows promise for rheumatoid arthritis self-administration. The Center for Biosimilars. June 19, 2025. Accessed July 1, 2025. https://www.centerforbiosimilars.com/view/tocilizumab-biosimilar-ct-p47-shows-promise-for-rheumatoid-arthritis-self-administration