[co-author: Joseph Molinari]
On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe.
Samsung Bioepis announced a licensing, development, and commercialization agreement with NIPRO Corporation for multiple biosimilar candidates in Japan. One of these candidates is SB17, a biosimilar of Janssen’s STELARA (ustekinumab). Under the agreement, Samsung Bioepis will be responsible for the development, manufacture, and supply of the biosimilars. NIPRO will be responsible for regulatory filings and commercialization in the Japanese market. This deal marks Samsung Bioepis’s first commercialization agreement in Japan.
The deal follows another agreement entered into by Samsung Bioepis and Sandoz in 2023 to develop and commercialize SB17 in the United States, Europe, Switzerland, the United Kingdom, and Brazil under the tradename PYZCHIVA.
Separately, Alvotech and Advanz announced an agreement to expand their partnership in Europe. This deal covers biosimilar candidates to ILARIS (canakinumab) and KESIMPTA (ofatumumab). The agreement between Alvotech and Advanz also covers a third early-stage biosimilar candidate that has not yet been disclosed. Alvotech will be responsible for managing the development and supply of these biosimilars, while Advanz will be responsible for registration and commercialization. Their $180 million deal features revenue sharing and builds on their 2023 agreements to commercialize biosimilars across Europe, the United Kingdom, Switzerland, Canada, Australia, and New Zealand.
Through this expanded agreement, the Alvotech-Advanz portfolio now covers more than ten biosimilar programs targeting major biologics, including XOLAIR (omalizumab), ENTYVIO (vedolizumab), SIMPONI (golimumab), EYLEA (aflibercept), DUPIXENT (dupilumab), TALTZ (ixekizumab), and TREMFYA (guselkumab).
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