Biosimilars Development Roundup: Expanding Global Options Amidst Rising US Legal Hurdles

The global biosimilar landscape continues to evolve as European regulators expand treatment options for patients with chronic conditions, while legal battles in the US highlight the ongoing tension between biosimilar manufacturers and originator companies over market entry.

European Regulators Recommend Approval for Fifth Teriparatide Biosimilar

On February 26, 2026, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending that a marketing authorization be granted for Zandoriah.1 Developed by CinnaGen, Zandoriah was designed as a biosimilar to the reference product Forsteo (teriparatide), which was produced by Eli Lilly.

Teriparatide is a recombinant form of parathyroid hormone (PTH). This agent serves as an anabolic, or bone-growing, treatment that activates osteoblasts to increase bone formation. The CHMP recommended Zandoriah for the treatment of postmenopausal women and men with osteoporosis who were at a high risk of fracture. Additionally, the recommendation covered patients with osteoporosis associated with sustained systemic glucocorticoid therapy.

Clinical data submitted to the committee demonstrated that Zandoriah possessed comparable quality, safety, and efficacy to its reference product. If the European Commission (EC) follows the recommendation, Zandoriah will become the fifth teriparatide biosimilar authorized in the European Union (EU), joining previously approved options such as Sondelbay and Terrosa. This marks the first biosimilar from CinnaGen to receive a positive CHMP opinion for the European market.

European Commission Grants Marketing Authorization for Gotenfia

Shortly before the recommendation for Zandoriah, the EC granted marketing authorization for Gotenfia (golimumab) on February 13, 2026.2 This biosimilar, which references Simponi, was developed through a partnership between Bio-Thera Solutions and STADA Arzneimittel AG. Gotenfia was approved for the treatment of patients with several chronic inflammatory autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

Gotenfia functions as a human monoclonal antibody that targets tumor necrosis factor alpha, a pro-inflammatory molecule. The authorization applied across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. As the second golimumab biosimilar approved in the EU, Gotenfia was expected to increase market competition and lower unit costs for biological treatments.

STADA, which held exclusive commercialization rights in the EU and UK, noted that this was its 11th biosimilar authorization. Bio-Thera remained responsible for the development and manufacturing of the product. Launch preparations were reported to be underway to bring this once-monthly treatment option to healthcare providers and their patients in the coming months.

Genentech Initiates Patent Litigation Against Biocon Over Pertuzumab

While European markets expanded, the US saw new legal hurdles for biosimilar entry. On February 27, 2026, Genentech filed a formal complaint at the US International Trade Commission (ITC) alleging that Biocon’s importation of a pertuzumab biosimilar, BMAB 1500, violated Section 337 of the Tariff Act. Biocon’s biologics license application (BLA) referenced Perjeta (pertuzumab), a therapy used for patients with HER2-positive breast cancer.

Genentech contended that Biocon imported more than 17,800 pieces of the biosimilar from India in October 2025. The complaint characterized this activity as "stockpiling" commercial supplies before receiving approval from the FDA. Genentech argued that such conduct fell outside the patent infringement "safe harbor," which typically protects importation solely for the development of information for federal regulatory review.

The litigation involved 4 asserted patents covering the pharmaceutical compositions and manufacturing methods of the antibody. Genentech sought a limited exclusion order to block the importation of the product until the patents expired, with the latest expiration date set for September 2031. Unlike district court litigations, ITC investigations generally reach a final decision within 16 months and focus on excluding infringing products from the border rather than awarding monetary damages. This legal action followed a similar case involving another pertuzumab biosimilar, Poherdy, which was approved by the FDA in November 2025 and settled in early 2026.

References

1. Generics and Biosimilars Initiative. EMA recommends approval for teriparatide biosimilar Zandoriah. Generics and Biosimilars Association. Published March 4, 2026. Accessed March 5, 2026. https://gabionline.net/biosimilars/news/ema-recommends-approval-for-teriparatide-biosimilar-zandoriah
2. Bio-Thera Solutions, Ltd., STADA, and Bio-Thera receive European marketing authorization for Gotenfia, a biosimilar to Simponi. Bio-Thera Solutions. News release. Published February 13, 2026. Accessed March 5, 2026. https://www.prnewswire.com/news-releases/stada-and-bio-thera-receive-european-marketing-authorization-for-gotenfia-a-biosimilar-to-simponi-302687571.html
3. Nock J, Wang S. ITC as a Biosimilar Battleground: Genentech Challenges Biocon's Pertuzumab Biosimilar. JD Supra. Published March 5, 2026. Accessed March 5, 2026. https://www.jdsupra.com/legalnews/itc-as-a-biosimilar-battleground-1228151/