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Biosimilars Regulatory Roundup: May 2025
FDA approvals for new biosimilars like Starjemza and Hadlima enhance treatment options, addressing urgent needs for affordability and policy reform.
The FDA’s recent approvals and interchangeability designations for multiple biosimilars mark significant strides in expanding affordable treatment options for complex diseases, even as US drug pricing and global regulatory challenges underscore the urgent need for policy reform and greater biosimilar adoption.
The FDA’s recent approvals and interchangeability designations for multiple biosimilars mark significant strides in expanding affordable treatment options for complex diseases, even as US drug pricing and global regulatory challenges underscore the urgent need for policy reform and greater biosimilar adoption.
New Regulatory Designations for Biosimilars in the US
The FDA has approved Starjemza (ustekinumab-hmny) as a biosimilar to Stelara for treating various rheumatic and gastrointestinal conditions.1 It is the eighth ustekinumab biosimilar approved in the US, developed under a partnership between Hikma Pharmaceuticals and Bio-Thera Solutions. The approval was supported by phase 1 and phase 3 studies showing comparable efficacy, safety, and immunogenicity to Stelara. Since February 2025, 6 ustekinumab biosimilars have launched in the US market, with Imuldosa still in the pipeline.
Additionally, 3 biosimilars have received interchangeability designations from the FDA.
One of these is Cimerli (ranibizumab-eqrn), an interchangeable biosimilar to Lucentis (ranibizumab) that was approved in August 2022.2 Cimerli is used to treat several retinal disorders, including neovascular age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. It matches the reference product in formulation, dosage, safety, efficacy, and immunogenicity, and must be administered via intravitreal injection by a qualified ophthalmic provider.
The other 2 biosimilars are Otulfi (ustekinumab-aauz) and Hadlima (adalimumab-bwwd).3 Otulfi, developed by Fresenius Kabi and Formycon AG, references Stelara and is approved for conditions such as Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis in both adults and children 6 years and older. It’s the first US launch from the Fresenius-Formycon collaboration and is available in injection and infusion forms. Its interchangeable status was granted based on data showing equivalent safety and efficacy to Stelara, including for patients who switch between products.
Meanwhile, Hadlima, a biosimilar to Humira, also received the interchangeability designation for both its high- and low-concentration formulations. Clinical trial data in patients with plaque psoriasis supported the designation, demonstrating comparable outcomes when switching between Hadlima and Humira. This expanded label could enhance access and affordability across multiple inflammatory conditions.
How International Regulatory Policies Could Be Improved
US drug pricing policies continue to face scrutiny amid high costs and limited regulation.4 Unlike many other countries with nationalized health systems and strict price controls, the US allows pharmaceutical companies to set and change prices freely. President Trump’s latest executive order seeks to implement “most-favored nation” pricing, aiming to align US drug prices with those in other countries. However, similar efforts in the past have faced legal setbacks, and even recent negotiated prices under the Inflation Reduction Act remain significantly higher than international benchmarks.
Development costs, pressure for shareholder returns, and limited price control contribute to high US drug prices. Further complicating the issue are pharmacy benefit manager (PBM) practices that often prioritize higher-cost originators over lower-cost generics and biosimilars. Despite bipartisan interest in reform, structural challenges—including PBM influence, lack of value-based pricing, and potential new pharmaceutical tariffs—continue to hinder meaningful change.
Biosimilar policies in the Middle East and North Africa (MENA) region face distinct challenges compared with the US.5 Despite the cost-saving potential of biosimilars and generics, adoption across MENA countries remains limited due to regulatory inconsistencies, knowledge gaps among health care providers, and cultural biases favoring branded drugs. A recent systematic review found that while pharmacists often support substitution, many physicians remain skeptical, particularly regarding biosimilars. Without harmonized regulations or targeted educational initiatives, uptake in the region continues to lag behind the more structured and policy-driven frameworks seen in the US and European Union.
In a recent opinion piece, Sarfaraz K. Niazi, PhD, highlights India’s 2025 draft guidelines on similar biologics from the Central Drugs Standard Control Organisation as a significant move toward harmonization with global regulatory standards.6 The guidelines align with those of the European Medicines Agency, the FDA, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency. Key advancements include reduced reliance on animal and confirmatory efficacy testing, a greater focus on in vitro evidence, and risk-based immunogenicity assessments. While progressive, Niazi emphasized the need for more clarity on statistical methods, pharmacodynamic biomarker validation, and extrapolation criteria to enhance consistency and global alignment.
Expert Insights on Biosimilar Regulations in a New Format
In the first in a new vodcast series, Craig Burton, executive director of the Biosimilars Council, and Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), co-host a deep dive into the evolving biosimilar landscape. Presented by The Center for Biosimilars® in partnership with AAM and the Biosimilars Council, this series explores the critical challenge of the "biosimilar void" — where 90% of biologics losing patent protection over the next decade currently have no biosimilar competition in development. Since 2010, biosimilars have generated $36 billion in savings for the US health care system, significantly enhancing patient access to affordable therapies. The vodcast underscores the urgent need for policy reforms and collaboration to break down barriers and sustain biosimilar growth for the benefit of patients and the broader health care system.
References
1. Jeremias S. FDA approves Starjemza as new Stelara biosimilar. The Center for Biosimilars. May 27, 2025. Accessed May 29, 2025. https://www.centerforbiosimilars.com/view/fda-approves-starjemza-as-new-stelara-biosimilar
2. Garcia M, Arakelians S. Cimerli offers a new, interchangeable biosimilar for ocular conditions. The Center for Biosimilars. May 15, 2025. Accessed May 29, 2025. https://www.centerforbiosimilars.com/view/cimerli-offers-a-new-interchangeable-biosimilar-for-ocular-conditions
3. Jeremias S. Eye on Pharma: interchangeability labels and expanded biosimilar partnerships. The Center for Biosimilars. May 29, 2025. Accessed May 29, 2025. https://www.centerforbiosimilars.com/view/eye-on-pharma-interchangeability-labels-and-expanded-biosimilar-partnerships
4. Jeremias S. The Trump administration’s drug price actions and why US prices are already sky-high. The Center for Biosimilars. May 17, 2025. Accessed May 29, 2025. https://www.centerforbiosimilars.com/view/the-trump-administration-s-drug-price-actions-and-why-us-prices-are-already-sky-high
5. Jeremias S. What stands in the way of biosimilar use across MENA countries? The Center for Biosimilars. May 21, 2025. Accessed May 29, 2025. https://www.centerforbiosimilars.com/view/what-stands-in-the-way-of-biosimilar-use-across-mena-countries-
6. Niazi SK. BioRationality: The revised Indian biosimilar guidelines finally bring rationality. The Center for Biosimilars. May 19, 2025. Accessed May 29, 2025. https://www.centerforbiosimilars.com/view/biorationality-the-revised-indian-biosimilar-guidelines-finally-bring-rationality
7. Jeremias S, Burton C, Randazzo G. Escaping the void: all things biosimilars with Craig & G. The Center for Biosimilars. May 4, 2025. Accessed May 29, 2025. https://www.centerforbiosimilars.com/view/escaping-the-void-all-things-biosimilars-with-craig-g
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
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