ARTICLE
10 December 2024

Biocon Announces FDA Approval Of Ustekinumab Biosimilar

GP
Goodwin Procter LLP

Contributor

At Goodwin, we partner with our clients to practice law with integrity, ingenuity, agility, and ambition. Our 1,600 lawyers across the United States, Europe, and Asia excel at complex transactions, high-stakes litigation and world-class advisory services in the technology, life sciences, real estate, private equity, and financial industries. Our unique combination of deep experience serving both the innovators and investors in a rapidly changing, technology-driven economy sets us apart.
On December 1, 2024, Biocon announced that the FDA has approved YESINTEK™ (ustekinumab-kfce), a biosimilar to J&J's STELARA®.
United States Food, Drugs, Healthcare, Life Sciences

On December 1, 2024, Biocon announced that the FDA has approved YESINTEK" (ustekinumab-kfce), a biosimilar to J&J's STELARA®. YESINTEK is approved for the treatment of Crohn's disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. According to the announcement, Biocon had entered into a settlement and licensing agreement with Janssen to commercialize YESINTEK in the United States no later than February 22, 2025, upon approval from the FDA.

YESINKTEK is the sixth ustekinumab biosimilar approved by the FDA, behind Amgen's WEZLANA (ustekinumab-auub), approved in Oct. 2023; Alvotech's SELARSDI (ustekinumab-aekn), approved in April 2024; Samsung Bioepis's PYZCHIVA (ustekinumab-ttwe), approved in July 2024; Fresenius Kabi's OTULFI (ustekinumab-aauz), approved in Sept. 2024; and Accord's IMULDOSA (ustekinumab-srlf), approved in Oct. 2024.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More