Samsung Bioepis and Teva have expanded their partnership through a license, development and commercialization agreement covering two investigational biosimilars, with an option to add four more candidates.
The two named products are SB41, a proposed biosimilar to Fasenra (benralizumab), and SB44, a proposed biosimilar to Ilaris (canakinumab). The companies will work toward bringing the candidates to markets including the United States, Europe and Canada, with an option to extend the arrangement to other territories.
Under the agreement, Samsung Bioepis will develop and manufacture the biosimilars and handle regulatory registrations. Teva will be responsible for commercialization. The arrangement divides the work between Samsung Bioepis’ product development and production operations and Teva’s sales network.
A biosimilar is a biologic medicine developed to be highly similar to an existing approved product. Both SB41 and SB44 remain investigational candidates.
The new agreement builds on the companies’ work with EpySQLI (eculizumab-aagh), which they have commercialized in the United States. They have also expanded an earlier agreement to cover OPUVIZ (aflibercept) in Canada.
Samsung Bioepis President and CEO Kyung-Ah Kim said the new candidates will extend the companies’ biosimilar work. Teva President and CEO Richard Francis described the multi-product agreement as part of the company’s effort to expand its biosimilars business.
The partnership initially identifies two candidates rather than six confirmed development programs. Whether the remaining four enter the collaboration will depend on the companies exercising the option in their agreement. The deal also establishes a framework for expansion beyond the United States, Europe and Canada.
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