This Monday, Bio-Thera Solutions and Dr. Reddy's Laboratories SA announced that they had entered into commercialization and licensing agreements for proposed ustekinumab and golimumab biosimilars in Southeast Asia. Bio-Thera will develop, manufacture, and supply BAT2206 (the proposed ustekinumab biosimilar referencing Janssen's STELARA) and BAT2506 (the proposed golimumab biosimilar referencing Janssen's SIMPONI), and Dr. Reddy's will seek regulatory approval and be responsible for commercialization of both BAT2206 and BAT2506 in various countries in Southeast Asia, as well as BAT2206 in Columbia.
In additional news on ustekinumab, the biosimilars SELARSDI, YESINTEK, and OTULFI launched in the US this past February and March:
- On February 21, 2025, Teva Pharmacuticals announced the U.S. launch of SELARSDI (ustekinumab-aekn). Pursuant to an August 2020 agreement and a July 2023 agreement between Teva and Alvotech, Teva is responsible for the exclusive commercialization of SELARSDI (ustekinumab-aekn), while Alvotech is responsible for development and manufacturing.
- On February 24, 2025, Biocon Biologics announced the U.S. launch of YESINTEK (ustekinumab-kfce). YESTINTEK received FDA approval in December 2024 based on the STELLAR-2 study.
- On March 3, 2025, Fresenius Kabi announced the U.S. launch of OTULFI (ustekinumab-aauz). As we previously reported, Fresenius Kabi and Formycon AG entered into a global license agreement to commercialize OTULFI in key global markets.
Like the reference product STELARA, biosimilars SELARSDI, YESINTEK, and OTULFI are indicated for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, patients 6 years or older with active psoriatic arthritis, adult patients with moderately to severely active Crohn's disease, and adult patients with moderately to severely active ulcerative colitis.
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