The first biosimilar was approved in the U.S. in 2015. And now, just over 10 years later, the U.S. Food & Drug Administration (FDA) has approved an additional 81 biosimilars. In 2025 alone, the FDA approved 18 new biosimilars for a range of indications. However, only 73% of those approved biosimilars have been launched as of September 2025.
Last year, the U.S. market size for biosimilars was estimated to be $22.59 billion. By 2034, that number could be more than $93.52 billion. In 2025, biosimilars for chronic conditions and autoimmune diseases made up the biggest revenue amount. Biosimilars for these conditions will likely continue to drive growth in the market.
Here are five biosimilars to watch this year:
1. In November 2025, Poherdy® was approved as the first interchangeable biosimilar for Perjeta® (pertuzumab). Poherdy can be used in conjunction with other medicines to treat various types of breast cancer. In 2024, sales for Perjeta were about $4.3 billion.
A patent infringement case was filed in New Jersey in August 2025 related to a portfolio of Perjeta patents. This could delay the launch of Poherdy, though it should be on the market this year.
2 .Eylea® (aflibercept), which treats wet age-related macular degeneration and diabetic eye disease, has six biosimilars. In 2024, sales of Eylea in the U.S. totaled almost $6 billion.
Two of the biosimilars are interchangeable, and four are not. The most recent approval was in October 2025 for Eydenzelt®, which is expected to be on the market on December 31, 2026.
In 2024, the two interchangeable biosimilars were approved: Yesafili™ and Opuviz™. These are not yet on the market due to issues regarding patent exclusivity for Eylea. However, Yesafili should be on the market this year. The launch date for Opuviz is unclear.
The other biosimilars for Eylea are Ahzantive®, Enzeevu™, and Pavblu®. Ahzantive is not on the market yet. Enzeevu is expected to be on the market by the fourth quarter of 2026 after settling patent litigation in September 2025. Pavblu has been available for over a year.
3. Prolia® (denosumab) is an injection to treat osteoporosis in women with an increased risk of fracture after menopause and in men with osteoporosis. In 2024, Prolia and Xgeva®, a sister medicine used for various types of cancer, had annual global sales of over $4 billion.
There are currently a number of biosimilars for Prolia, including eight that were approved in 2025. The first interchangeable biosimilar for Prolia, Jubbonti®, was approved in March 2024 and became available in June 2025. Stoboclo®, approved in February 2025, and Conexxence, approved in March 2025, both became available in July 2025.
The most recent approval was for Boncresa™ in January 2026. Several other biosimilars for Prolia are in development. With the increased number of biosimilars for Prolia comes increased competition.
4. In March 2025, Omlyclo® was approved as a biosimilar for Xolair® (omalizumab), which helps to lessen symptoms and frequency of asthma attacks, hives, nasal polyps, and allergic reactions. Xolair made about $2.8 billion in the first nine months of 2025.
Omlyclo is the first and only interchangeable biosimilar for Xolair and could be launched in the U.S. as early as September 2026.
5. There are now about eight biosimilars for Stelara® (ustekinumab), which treats Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. In 2025, Stelara had annual sales of about $6 billion.
All the biosimilars—Wezlana®, Selarsdi™, Pyzchiva™, Otulfi®, Imuldosa®, Yesintek™, Steqeyma®, and Starjemza™—are on the market, meaning competition could be fierce. Wezlana was approved in October 2023, the first biosimilar for Stelara to be approved. The most recent approval was for Starjemza in May 2025. It became available at the end of last year.
The biosimilars market is heating up in 2026, driven by patent expirations, increased competition, and greater demand for cost-effective medications. The continued adoption of biosimilars could mean more savings, more access, and a more sustainable drug landscape in the future.
Interested in navigating biosimilars? Contact Scott Webb at [email protected].
