In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz / Samsung Bioepis’s Pyzchiva® (ustekinumab-ttwe) that has provisionally been approved as interchangeable, and the total Humira® interchangeables to six.
These approvals bring the total interchangeable biosimilar approvals in the US to 22, 15 of which have been approved in 2024-25. The increased number of interchangeable approvals has come after the FDA has sought to lessen the burden of proving interchangeability, including revising its interchangeability guidance in June 2024 to eliminate the switching study requirement for many drugs (previously reported FDA Revises Guidance on Switching Studies for Biosimilar Interchangeability).
On May 5, 2025, Alvotech and Teva announced the FDA-approval of Selarsdi™ (ustekinumab-aekn) as interchangeable with Stelara®. Selarsdi™ was originally approved as biosimilar in April 2024 and launched in February 2025. On May 19, 2025, Fresenius Kabi and Formycon announced Otulfi®’s (ustekinumab-aauz) interchangeable approval. Otulfi® was originally approved as biosimilar to Stelara® in September 2024 and launched in March 2025. On May 22, 2025, the FDA approved Bio-Thera and Hikma’s Starjemza® (ustekinumab-hmny) as an interchangeable biosimilar of Stelara®.
On May 20, 2025, the FDA expanded its interchangeability designation for Celltrion’s Yuflyma® (adalimumab-aaty) to all approved dosage forms and strengths, and it is now fully interchangeable with Humira®. Yuflyma® was initially approved in May 2023 as a high-concentration interchangeable for prefilled 20 and 80mg syringes. The new interchangeability designation added the 40mg syringe and 40 and 80mg autoinjector presentations.
On May 27, 2025, the FDA expanded the interchangeability designation for Samsung Bioepis and Organon’s Hadlima™ (adalimumab-bwwd). Hadlima™ was originally approved as a low-concentration Humira® biosimilar in July 2019 and received an interchangeability designation for low-concentration 40mg/0.8mL prefilled syringes and single dose vials in June 2024. It was approved in a high-concentration formulation in August 2022, and it is now fully interchangeable with all of Humira®’s presentations.
For more information on these and other biosimilars, please visit BiologicsHQ.
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The author would like to thank April Breyer Menon for her contributions to this article.
