Biosimilar Update: 2025 Brings More FDA Approvals & Interchangeability

Using biosimilar medications can improve patient access to care, increasing the number of medication options available and potentially lowering medication costs.

Biosimilars are highly similar to and have no clinically meaningful differences from an existing biologic treatment that is approved by the U.S. Food & Drug Administration (FDA). These approved biologic medications are often referred to as reference products for biosimilars.¹ Thus, patients can expect the same safety and effectiveness from the biosimilar as the reference product. 

An interchangeable biosimilar is a medication that has met other legal requirements and can be substituted for the reference product without consulting the prescriber. The substitution may occur at the pharmacy—subject to pharmacy laws, which vary by state—similarly to how generic drugs are substituted for brand-named drugs at a pharmacy. Prescribers can also specify for a biosimilar agent not to be substituted for or interchanged with the designated brand-named biologic medication.

Currently FDA Approved

In a prior column, we reported that the FDA had approved denosumab-bbdz (Jubbonti) as an interchangeable biosimilar for denosumab (Prolia), as well as denosumab-bbdz (Wyost) as an interchangeable biosimilar for denosumab (Xgeva).¹ These two denosumab biosimilars offer more affordable treatment options for patients with osteoporosis, bone metastases and other bone-related conditions for which these agents are approved.

On March 4, 2025, the FDA approved denosumab-bmwo (Steoboclo) as interchangeable with Prolia and denosumab-bmwo (Osenvelt) as interchangeable with Xgeva for all indications of the reference products. In February 2025, the FDA approved denosumab-dssb (Ospomyv and Obodence).²  

Currently, there are nine FDA-approved biosimilars with adalimumab (Humira) as the reference product, the first of which was adalimumab-atto (Amjevita), which was approved in September 2016 as interchangeable with adalimumab (Humira).^3,4

Subsequent FDA approvals for other biosimilars referencing adalimumab (Humira):

• Adalimumab-abdm (Cytelzo) in August 2017;
• Adalimumab-adaz (Hyrimoz) in October 2018;
• Adalimumab-bwwd (Hadlima) in July 2019;
• Adalimumab-afzb (Abrilada) in November 2019;
• Adalimumab-fkjp (Hulio) in July 2020;
• Adalimumab-aqvh (Yusimry) in December 2021;
• Adalimumab-aacf (Idacio) in December 2022;
• Adalimumab-aaty (Yuflyma) in May 2023; and
• Adalimumab-ryvk (Simlandi) in February 2024.

As of this writing, a total of seven biosimilars are now interchangeable with adalimumab (Humira), the most recent of which is adalimumab-aaty (Yuflyma), which received this designation on April 14.⁵ The other interchangeable products are Amjevita, Cytelzo, Hyrimoz, Abrilada, Hulio and Simlandi.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer [news release]. U.S. Food & Drug Administration. 2024 Mar 5.
2. Jeremias S, McNulty R. FDA approves third pair of denosumab biosimilars. The Center for Biosimilars. 2025 Mar 4.
3. Biosimilar product information: FDA-approved biosimilar products. U.S. Food & Drug Administraion. 2025 Mar 15.
4. Purple Book: Database of licensed biological products. U.S. Food & Drug Administration. 2025 Mar 27.
5. U.S. FDA grants interchangeable designation to Yuflyma (adalimumab-aaty), Celltrion’s biosimilar to Humira (adalimumab) [news release]. Celltrion Inc. PR Newswire. 2025 Apr 14.