What biosimilar candidates are Samsung Bioepis and Teva commercializing together?

The deal covers up to six potential biosimilar candidates. Two confirmed investigational candidates are SB41, referencing AstraZeneca’s Fasenra, and SB44, referencing Novartis’ Ilaris.

Who will handle development and commercialization under Samsung Bioepis and Teva’s agreement?

Samsung Bioepis will be responsible for development, regulatory registration and manufacturing. Teva will handle commercialization in global markets, including the U.S., Europe and Canada, with an option to expand the partnership to other territories.

How does the Samsung Bioepis and Teva deal build on their existing partnership?

Samsung Bioepis said the agreement reinforces an existing partnership that already led to the commercialization of Epysqli in the U.S. and the expansion of Opuviz in Canada. Samsung Bioepis CEO Kim Kyung-ah and Teva CEO Richard Francis both described the new agreement as a major step in strengthening the collaboration.

Samsung Bioepis, Teva enter commercialization agreement on 6 biosimilar candidates

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Summary

Samsung Bioepis and Teva Pharmaceutical Industries have signed a global licensing, development and commercialization agreement for up to six potential biosimilar candidates on Thursday. The two confirmed candidates are SB41, referencing AstraZeneca’s Fasenra, and SB44, referencing Novartis’ Ilaris. Samsung Bioepis will handle development, regulatory registration and manufacturing, while Teva will commercialize the biosimilars in the U.S., Europe and Canada.

Key Facts

The agreement covers up to six potential biosimilar candidates, including two confirmed investigational candidates.
SB41 references AstraZeneca’s Fasenra, which is used primarily for severe eosinophilic asthma.
SB44 references Novartis’ Ilaris, which treats inflammatory conditions including rare autoinflammatory diseases.
Teva will commercialize the biosimilars in global markets, including the U.S., Europe and Canada, while Samsung Bioepis will handle development, regulatory registration and manufacturing.
The companies said the partnership builds on earlier commercialization work on Epysqli in the U.S. and Opuviz in Canada.

By Nam Hyun-woo

Published Oct 1, 2026 5:56 pm KST

Samsung Bioepis office in Incheon / Courtesy of Samsung Bioepis

Samsung Bioepis and Teva Pharmaceutical Industries have entered into an agreement on commercializing the former’s up to six potential biosimilar candidates, including two confirmed investigational candidates, the companies said Thursday.

According to Samsung Bioepis, the two sides have signed a global licensing, development and commercialization agreement for the potential candidates.

Of them, two confirmed investigational biosimilar candidates are SB41, referencing AstraZeneca’s Fasenra, a treatment primarily used for severe eosinophilic asthma, and SB44, referencing Novartis’ Ilaris, which treats a range of inflammatory conditions including rare autoinflammatory diseases.

Under the terms of the agreement, Samsung Bioepis will be responsible for the development, regulatory registration and manufacturing of the biosimilars, while Teva will be responsible for commercialization in global markets, including the U.S., Europe and Canada. The companies have agreed to an option for expanding the partnership to other territories.

Samsung Bioepis said the agreement reinforces their existing partnership, which has already led to the commercialization of Epysqli, a treatment for rare and difficult-to-treat diseases, in the U.S. The companies have also expanded the partnership to include Opuviz, a treatment for eye diseases, in Canada.

“We are thrilled to expand our successful partnership with Teva with these new biosimilar candidates,” Samsung Bioepis CEO Kim Kyung-ah said. “This agreement marks another milestone in our shared journey to improve patient access to life-changing medicines.”

Teva CEO Richard Francis said the global multiproduct agreement is a significant step in scaling Teva’s biosimilars business. “By combining a strong and growing portfolio and our excellent global commercial capabilities, we are strengthening our leadership position in biosimilars and our ability to bring more treatment options to patients around the world,” Francis said.

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