Biosimilar Market Momentum: EU Approvals, Strategic Launches, and Major US Partnerships

The biosimilar landscape experienced significant expansion in late 2025, marked by crucial regulatory progress in Europe across immunology and bone health, alongside major strategic agreements positioning companies for key launches in the high-value North American oncology market. Recent news demonstrated how companies strengthened their portfolios by securing positive opinions from the Committee for Medicinal Products for Human Use (CHMP), announcing launches for high-demand therapies, and forging new alliances.

European Regulatory Momentum in Autoimmune Diseases

The European market saw 2 major biosimilar candidates receive positive recommendations from the CHMP, setting the stage for increased access to treatments for people living with chronic inflammatory conditions.1

Celltrion received a positive CHMP opinion for the autoinjector presentation of SteQeyma (ustekinumab biosimilar). SteQeyma, a biosimilar to Stelara, was developed for the treatment of people with plaque psoriasis, psoriatic arthritis, and Crohn disease. The positive opinion specifically covered the 45-mg and 90-mg solutions for injection via autoinjector. The availability of the autoinjector option aimed to improve convenience and enhance the individual patient experience by expanding administration options. Celltrion noted that the autoinjector utilized a simple two-step administration process, which included clear visual and audible indicators to help people easily identify the injection status. The autoinjector formulation was also citrate-free and featured special thin-wall needle technology intended to reduce injection pain. This new administration option joined the currently approved presentations of SteQeyma, including pre-filled syringes and vials for subcutaneous injection, as well as concentrate for intravenous infusion.

In a separate announcement, STADA Arzneimittel and Bio-Thera Solutions received a positive CHMP opinion recommending approval for their biosimilar candidate, Gotenfia (golimumab).2 Gotenfia, which references Simponi, was recommended for marketing authorization for people with several chronic inflammatory autoimmune diseases. These conditions included rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and ulcerative colitis in adult patients. The positive recommendation also covered juvenile idiopathic arthritis in people aged 2 years and older. Gotenfia was developed by Bio-Thera, who retained responsibility for manufacturing and supply, while STADA secured the exclusive rights for commercialization across the European Union, the UK, Switzerland, and other selected countries.

Expanding Access Through New Launches in Bone Health and Ophthalmology

Biosimilar launches in Europe broadened therapeutic access in bone health and ophthalmology, areas where current treatment costs place a high burden on health care systems.

Accord Healthcare announced the launch of 2 denosumab biosimilars following the scheduled expiration of the reference medicine’s patent on November 27, 2025.3 These launches included Osvyrti, a biosimilar referencing Prolia, and Jubereq, a biosimilar referencing Xgeva. Both medicines received approval from the European Medicines Agency in September 2025, after trials demonstrated they were highly similar to their reference products. Osvyrti, available as a 60-mg prefilled syringe, was indicated for the treatment of people with osteoporosis and bone loss linked to hormone ablation in men with prostate cancer.

Jubereq, available as a 120-mg vial, was indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. Accord Healthcare stated that these biosimilars possessed the potential to provide treatment alternatives that helped lessen cost as a barrier for people accessing proven therapies.

Meanwhile, Sandoz announced the European launch of Afqlir (aflibercept), providing an affordable treatment option for people with retinal diseases.4 Afqlir, approved by the European Commission in November 2024, matched the reference medicine, Eylea, in efficacy, safety, and pharmacokinetics. The biosimilar, available as a 2-mg vial kit and pre-filled syringe for intravitreal injection, was indicated for the same indications as Eylea in adult patients.

Aflibercept is considered a gold standard treatment for various neovascular retinal diseases, which are leading causes of vision loss. The launch of Afqlir aimed to bring a high-quality, affordable aflibercept option for European people that maintains and improves vision while supporting more sustainable care across the region.

Strategic Partnership Targets US Oncology Market

Formycon AG and Zydus Lifesciences Limited cemented a partnership focused on penetrating the lucrative North American oncology biosimilar market.4 The companies jointly announced a strategic collaboration for the exclusive licensing and supply of FYB206, a biosimilar of Keytruda (pembrolizumab), in the US and Canada. Under the agreement, Formycon committed to finalizing development, preparing and filing the regulatory dossier, and supplying the product. Zydus assumed responsibility for the commercialization of FYB206 in both the US and Canada.

Pembrolizumab is a humanized monoclonal antibody used to treat various tumors, and its reference product, Keytruda, was one of the world’s best-selling drugs in 2024. Formycon anticipated receiving primary endpoint data from the clinical development phase of FYB206 in the first quarter of 2026, leading to the eventual submission of a biologics license application to the FDA. Zydus noted that this venture marked its entry into the North American biosimilar market, beginning with an immunotherapy product.

References

1. Sandoz launches Afqlir (aflibercept) in Europe, providing affordable treatment option for patients with retinal diseases. News release. Sandoz. November 11, 2025. Accessed December 18, 2025. https://www.sandoz.com/sandoz-launches-afqlirr-aflibercept-europe-providing-affordable-treatment-option-patients-retinal/
2. Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion. News release. Bio-Thera Solutions. December 12, 2025. Accessed December 18, 2025. https://www.prnewswire.com/news-releases/golimumab-biosimilar-gotenfia-from-stada-and-bio-thera-receives-positive-chmp-opinion-302640091.html
3. Accord Healthcare announces launch of denosumab - second biosimilar in bone health. News release. Accord Healthcare. December 2, 2025. Accessed December 18, 2025. https://www.prnewswire.com/news-releases/accord-healthcare-announces-launch-of-denosumab---second-biosimilar-in-bone-health-302629590.html
4. Celltrion receives positive CHMP opinion for SteQeyma (ustekinumab biosimilar) autoinjector. News release. Celltrion. December 18, 2025. Accessed December 18, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/4348
5. Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206, a biosimilar to Keytruda (Pembrolizumab), in the U.S. and Canada. News release. Formycon. December 9, 2025. Accessed December 18, 2025. https://www.globenewswire.com/news-release/2025/12/09/3202239/0/en/Formycon-and-Zydus-partner-for-exclusive-licensing-and-supply-agreement-of-FYB206-a-biosimilar-to-Keytruda-Pembrolizumab-in-the-U-S-and-Canada.html