Written by Rikesh Dighore (Pharmacology) and Soniya Hajare (Pharmacology)
The European Medicines Agency’s (EMA) Committee for Medicinal Product for Human Use (CHMP) has accepted a positive opinion for Qoyvolma (ustekinumab), a biosimilar of the reference biologic Stelara. This approval is a significant step towards treatment of chronic inflammatory diseases. Qoyvolma is approved for use in adults and children aged six and older with plaque psoriasis, as well as in adults with psoriatic arthritis, Crohn’s disease, and ulcerative colitis. These immune-mediated conditions are marked by chronic inflammation that can significantly affect patients’ quality of life. Developed by Celltrion Healthcare Hungary Kft, the biosimilar’s approval ensures persistent therapeutic benefits at the same time it lowers the financial burden and increases access to biological treatment by potentially lowering healthcare costs.
Background and Need for New Treatment
Plaque psoriasis is a chronic, immune-mediated skin condition that affects both adults and children. In pediatric populations, it represents about one-third of all psoriasis cases and is often linked to serious co-morbidities, including a heightened risk of developing psoriatic arthritis and inflammatory bowel diseases such as Crohn’s disease. Psoriatic arthritis (PsA), a diverse form of inflammatory arthritis, occurs in up to 41% of individuals with psoriasis and can result in progressive joint damage and disability if not identified and managed early.
Crohn’s disease and ulcerative colitis are chronic inflammatory bowel diseases marked by recurrent episodes of inflammation in the gastrointestinal tract. Although several treatment options exist, including biologic therapies, many patients continue to face challenges such as suboptimal disease control, a lack of effect over time, or intolerable side effects. These limitations underline the ongoing need for new and effective therapeutic approaches.
Despite several progressions in the treatment of plaque psoriasis, psoriatic arthritis (PsA), Crohn’s disease, and ulcerative colitis (UC), there remains a need for more effective, safer, and longer-lasting therapies. In plaque psoriasis includes pediatric cases, biologics targeting TNF-α, IL-17, and IL-23 pathways which generally deliver only partial or short-term relief, with many patients experiencing relapse or an inadequate response. Psoriatic arthritis poses similar challenges, as a significant number of patients fail to achieve or sustain remission, emphasizing the need for treatments with novel mechanisms. Likewise, in Crohn’s disease and ulcerative colitis, even with the emergence of newer agents, an ample proportion of patients do not achieve deep, lasting remission, and treatment-related adverse effects remain a concern.
Also, Biologics have revolutionized the treatment of chronic and complex diseases, but their high prices often place them out of reach for many patients and healthcare systems, especially in low- and middle-income regions.
These persistent limitations and the need for cost-effective options highlight the ongoing demand for innovative therapies that can provide durable disease control, lower financial burden, and significantly enhance patient quality of life across this spectrum of immune-mediated conditions.
Qoyvolma (ustekinumab): A Novel Approach
Qoyvolma is a biosimilar of ustekinumab. Ustekinumab is a fully human IgG1κ monoclonal antibody that targets the p40 subunit common to interleukins IL-12 and IL-23. By blocking their interaction with the IL‑12Rβ1 receptor on immune cells, it disrupts the activation of the Th1 and Th17 cytokine pathways, which are key drivers in the inflammatory processes underlying these chronic immune-mediated conditions.
Being a biosimilar, the approval of Qoyvolma introduces a more accessible and cost-effective approach to the treatment of chronic inflammatory diseases. By offering clinically comparable alternatives to the reference biologic, these biosimilar have the potential to expand patient access to advanced therapies while alleviating the financial burden on healthcare systems. Their availability supports broader, more sustainable management strategies for conditions like plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Qoyvolma is offered in multiple formulations: 45 mg and 90 mg solutions for subcutaneous injection and a 130 mg concentrate for intravenous infusion, providing flexibility in administration to suit individual patient needs. The arrival of Qoyvolma and other ustekinumab biosimilars marks a meaningful advancement in the treatment for chronic inflammatory diseases, delivering effective, more accessible therapeutic options that can improve patient outcomes and support long-term disease management.
Clinical Trials and Approval
As per EMA, Qoyvolma has comparable quality, safety, and efficacy to Stelara
Safety profile
As being biosimilar to Stelara, Qoyvolma (Ustekinumab) has a favorable safety profile similar to Stelara and is generally well tolerated. Common side effects include upper respiratory infections, headache, fatigue, and mild injection site reactions. Serious adverse events are rare but can include infections such as tuberculosis and opportunistic infections, so screening is recommended before starting therapy. There is a very low risk of malignancy, hypersensitivity reactions, and rare neurologic effects like reversible posterior leukoencephalopathy syndrome (RPLS). The drug has low immunogenicity, meaning the development of anti-drug antibodies is uncommon. Long-term studies have shown no significant increase in infections or malignancy rates over time. It is considered relatively safe in pregnancy and breastfeeding, and no dose adjustments are required in elderly patients or those with liver or kidney issues.
Impact and Conclusion
Qoyvolma is anticipated to significantly lower treatment costs for healthcare systems while broadening access to advanced therapies, especially in regions where biologic medications were previously out of reach due to financial constraints. Its introduction strengthens competition in the biosimilar market, encourages innovation, improves pricing dynamics, and enhances trust in the use of biosimilars across Europe. Looking ahead, Qoyvolma is well-positioned to contribute to the continued expansion of the biosimilar market. Potentially accelerating the development and regulatory approval of additional ustekinumab biosimilars. Its success may also lead to expanded indications, including pediatric Crohn’s disease, as patent exclusivity expires. Moreover, regulatory approval in Europe could serve as a model for market entry in other global regions, supporting wider acceptance and integration of biosimilars into the healthcare system worldwide.
Ultimately, Qoyvolma marks a shift in treatment paradigms, helping establish biosimilars as a mainstream option in the long-term management of chronic inflammatory disease.
References
Kim HO, Kang SY, Kim JC, Park CW, Chung BY. Pediatric psoriasis: From new insights into pathogenesis to updates on treatment. Biomedicines. 2021 Aug 2;9(8):940.
Summary of opinion, Qoyvolma, 27 march 2025 available form https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-qoyvolma_en.pdf
Ferrara F, Verduci C, Laconi E, et al, Current therapeutic overview and future perspectives regarding the treatment of psoriasis. International Immunopharmacology. 2024 Dec 25;143:113388.
Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab safety in psoriasis, psoriatic arthritis, and Crohn’s disease: an integrated analysis of phase II/III clinical development programs. Drug safety. 2019 Jun 4;42:751-68.
Highlights of Prescribing Information, STELARA (Ustekinumab), available from https://janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf
The Article is Extensively Reviewed and Fact-Checked By the Editorial Team Pharmacally.com.
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