Biosimilars in 2025: A year of firsts

The biosimilar market is beginning to see the impact of a regulatory change made last year. In June 2024, the FDA issued a draft guidance that ended the need for switching studies for interchangeability designations of biosimilars. This has cut timelines and costs for manufacturers, allowing them to speed development of biosimilars.

In 2025, the biosimilar market saw 16 new approvals as of the beginning of December and the launch of a new class of biosimilars. One new first in biosimilars is the FDA approval of Poherdy (pertuzumab), which was approved by the FDA in November 2025. Poherdy, marketed by Organon, is an HER2/neu receptor antagonist to treat adults with HER2-positive breast cancer. It is a biosimilar that is an interchangeable biosimilar with Genentech’s Perjeta (pertuzumab).

Poherdy is approved for two key indications. The first is for use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. This combination has long been a foundational approach for HER2-positive metastatic breast cancer, targeting the overexpressed HER2 protein while simultaneously disrupting cancer cell proliferation.

In another notable first, the FDA approved Omlyclo (omalizumab-igec) in March 2025 as a biosimilar of Xolair (omalizumab). It is approved for several indications, including moderate-to-severe asthma, rhinosinusitis with nasal polyps, IgE-mediated food allergy and chronic spontaneous urticaria. It is approved as a subcutaneous injection in several strengths: 75 mg/0.5 mL, 150 mg/mL and 300 mg/2 mL.

Omlyclo is the first and only approved interchangeable biosimilar that references Xolair, but it is not yet available in the United States. It is expected to be launched in September 2026.

Within the diabetes space, an important first is the February 2025 approval of Sanofi’s Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) to improve glycemic control in adults and pediatric patients with diabetes.

Merilog is a rapid-acting human insulin analog and is the first rapid-acting insulin biosimilar product approved by the FDA. It helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes. The approval is for both a 3-milliliter single-patient-use prefilled pen and a 10-milliliter multiple-dose vial. Merilog is administered subcutaneously.

This was followed by the July 2025 approval of Biocon Biologics’ Kirsty (insulin aspart-xjhz), an interchangeable biosimilar of Novolog. Kirsty is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. It is available as a single-patient-use prefilled pen for subcutaneous use and a multiple-dose vial for subcutaneous and intravenous use.

In another first, Sandoz launched in November 2025 the first FDA-approved biosimilar of Tysabri (natalizumab). Tyruko (natalizumab-sztn) is used to treat adult patients with relapsing multiple sclerosis and patients with moderate-to-severe Crohn’s disease.

Sandoz has partnered with Labcorp to develop a test to detect anti-JCV antibodies, which can lead to the development of multifocal leukoencephalopathy (PML), a rare brain infection caused by the John Cunningham virus. This virus can occur in patients with an immune system weakened by immunosuppressant drugs. Natalizumab products are only available through a restricted drug distribution program due to the increased risk of PML.

The Prolia/Xgeva biosimilars

2025 also saw the launch of the first biosimilars for denosumab that reference Amgen’s osteoporosis drug Prolia and the bone cancer drug Xgeva. Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).

The first approvals for denosumab were approved in March 2024. Developed by Sandoz, both biosimilars are interchangeable with the reference products for all indications. Jubbonti references Prolia, and Wyost references Xgeva. This year, seven additional sets of denosumab have been approved by the FDA. These include:

• Aukelso and Bosaya (denosumab-kyqq), approved September 2025; launched October 2025
• Bildyos and Bilprevda (denosumab-nxxp), approved August 2025; launched in September 2025
• Bomyntra and Conexxence (denosumab-bnht), approved March 2025; launched in July 2025
• Enoby and Xtrenbo (denosumab-qbde), approved September 2025
• Ospomyv and Xbryk (denosumab-dssb), approved February 2025
• Osvyrti and Jubereq (denosumab-desu), approved October 2025
• Stoboclo and Osenvelt (denosumab-bmwo), approved February 2025; launched in July 2025

This past year, several of the denosumab have launched. The first was Jubbonti and Wyost, which launched in June 2025. At the time of launch, a Sandoz spokesperson said both products were priced at $26.74/mg. This is 7% lower than Xgeva and 14.5% lower than Prolia. The company anticipates coverage of these products across most plans. Wyost and Jubbonti have the same Medicare Part B (fee for service) coverage as Prolia and Xgeva, with no step edits or prior authorization required. This accounts for 35% to 40% of the market, according to the Sandoz spokesperson.

In July, two additional pairs of denosumab biosimilars from Fresenius Kabi and Celltrion launched. From Fresenius Kabi, Conexxence references Prolia and Bomyntra is a biosimilar referencing Xgeva. From Celltrion, Stoboclo references Prolia, while Osenvelt references Xgeva. Another set launched in September: Bildyos preferences Prolia and Bilprevda, which references Xgeva.

Even a small discount of 5% for a biosimilar that references Xgeva and Prolia could mean millions of dollars of savings for a health plan, according to a budget impact model published online at the Journal of Medical Economics in October 2025.

“In a hypothetical health plan covering 1 million lives, adding biosimilar denosumab to a health plan formulary may contribute to significant cost savings; savings can be reinvested to further expand access to biosimilar denosumab,” the authors wrote.