Eye on Pharma: Global Approvals, Launches, and Strategic Partnerships

The biosimilar landscape experienced significant expansion in late 2025 and early 2026, marked by crucial regulatory progress in Europe and strategic moves in North America. These developments enhance access to innovative treatments for people living with chronic conditions in immunology, oncology, and bone health.

European Regulatory Gains in Autoimmune Disease

The European market saw 2 major biosimilar candidates receive positive recommendations from the CHMP, setting the stage for increased access for people living with chronic inflammatory conditions.1 Celltrion received a positive opinion for the autoinjector presentation of SteQeyma (ustekinumab), a biosimilar referencing Stelara. Developed for people with plaque psoriasis, psoriatic arthritis, and Crohn disease, the autoinjector was designed to improve convenience and the individual patient experience through a simple two-step administration process.

Additionally, STADA Arzneimittel and Bio-Thera Solutions received a positive CHMP opinion for their biosimilar candidate, Gotenfia (golimumab), which references Simponi. The recommendation covered marketing authorization for several conditions, including rheumatoid arthritis and ulcerative colitis in adults, as well as juvenile idiopathic arthritis in people aged 2 years and older. While Bio-Thera retained manufacturing responsibilities, STADA secured exclusive commercialization rights across the European Union and the UK.

Broadening Access in Bone Health and Ophthalmology

Launches in Europe also targeted areas where high treatment costs have historically burdened health care systems. Accord Healthcare launched 2 denosumab biosimilars: Osvyrti, referencing Prolia, and Jubereq, referencing Xgeva.2 These medicines provided alternatives for people with osteoporosis or bone loss linked to cancer treatments. Samsung Bioepis also entered this space, launching its own denosumab biosimilars, Obodence and Xbryk, in December 2025 and January 2026, respectively.

In ophthalmology, Sandoz announced the European launch of Afqlir (aflibercept), a biosimilar to Eylea, for people living with retinal diseases. Furthermore, Samsung Bioepis began direct commercialization of Byooviz (ranibizumab), a biosimilar to Lucentis, in Europe. The company successfully transferred commercial rights back from Biogen and planned to introduce a pre-filled syringe (PFS) presentation in the second quarter of 2026.

US Market Focuses on Affordability and Pediatrics

In the US, CivicaScript, a nonprofit company, announced the availability of 2 significant low-cost products: insulin glargine-yfgn and ustekinumab-aauz.3 Their insulin glargine-yfgn is interchangeable with Lantus and was offered at a transparent, stable price of no more than $55 per box of 5 pre-filled pens for consumers. Similarly, their ustekinumab-aauz, interchangeable with Stelara, was launched with a transparent Wholesale Acquisition Cost (WAC) to help lower costs for health plans and people with chronic inflammatory conditions.

Focusing on specialized needs, Fresenius Kabi introduced a new presentation of Otulfi (ustekinumab-aauz) in a 45 mg/0.5 mL single-dose vial. This addition was specifically intended to provide dosing flexibility for pediatric patients weighing less than 60 kilograms who have plaque psoriasis or psoriatic arthritis. Otulfi previously received an interchangeability designation from the Food and Drug Administration (FDA) in May 2025.

References

1. https://www.businesswire.com/news/home/20260106192986/en/Fresenius-Kabi-Introduces-New-Presentation-of-Otulfi-ustekinumab-aauz-a-Biosimilar-to-Stelara
2. https://www.businesswire.com/news/home/20260102921713/en/Samsung-Bioepis-Begins-Commercialization-of-BYOOVIZ-Biosimilar-to-Lucentis-Ranibizumab-in-Europe
3. CivicaScript announces availability of low-cost insulin and biosimilar for chronic inflammatory conditions in the US. January 5, 2026. Accessed January 12, 2025. News release. CivicaScript. https://www.prnewswire.com/news-releases/civicascript-announces-availability-of-low-cost-insulin-and-biosimilar-for-chronic-inflammatory-conditions-in-the-us-302652087.html