Companies join forces to commercialize proposed biosimilar
Deal gives Alvotech direct U.S. role, Lotus exclusive rights in 8 Asian markets
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- Alvotech and Lotus Pharmaceutical partnered to commercialize AVT87, a proposed biosimilar to the hemophilia A treatment Hemlibra.
- Hemophilia A is a bleeding disorder caused by a deficiency of factor VIII, a protein needed for blood clotting.
- The partnership covers potential U.S. commercialization and aims to broaden access to biologic medicines across eight Asian markets.
Alvotech and Lotus Pharmaceutical are teaming up on plans to commercialize AVT87, a proposed biosimilar to Hemlibra (emicizumab).
Lisa Graver, CEO of Alvotech, said in a company press release that the companies “look forward to working together” to broaden access to high-quality biologics.
Hemlibra is an antibody-based therapy approved in the U.S. for routine prophylaxis to prevent or reduce bleeding episodes in children and adults with hemophilia A, with or without factor VIII inhibitors. The therapy, which works by mimicking the activity of the clotting protein whose deficiency causes hemophilia A, is also approved in many other countries worldwide. It is given by injection under the skin.
How biosimilars may expand treatment access
Hemlibra is a biologic, meaning it is manufactured using living cells. Biosimilars are medications designed to closely match name-brand biologics — similar to how generic medicines contain the same active ingredient as name-brand drugs, but with different regulatory requirements and terminology. Like generics, biosimilars can increase competition in the pharmaceutical marketplace and may help lower treatment costs.
Under the new agreement, Alvotech will be permitted to market AVT87 directly in the U.S. if the biosimilar is approved by the U.S. Food and Drug Administration (FDA), while Lotus will commercialize the biosimilar through Alvogen, its U.S.-based wholly owned subsidiary. Lotus also will have exclusive commercialization rights in eight Asian markets: South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong, and Malaysia. The agreement also covers AVT34, a proposed biosimilar to the cancer therapy Imfinzi (durvalumab).
“This agreement represents an important evolution of Alvotech’s commercial strategy,” Graver said. “For the first time, we will have the opportunity to participate directly in the future commercialization of our products in the United States, allowing us to retain a greater share of the value we create through our development and manufacturing platform. At the same time, our partnership with Lotus extends the potential reach of these two important pipeline assets across key Asian markets.”
Under the agreement, Alvotech will be responsible for developing AVT87 and obtaining and maintaining U.S. marketing authorization. It also will serve as the exclusive supplier of the product in all markets. Alvotech is eligible for up to approximately $150 million in upfront and milestone payments.
“We are pleased to partner with Alvotech on two important biosimilar candidates that meaningfully advance Lotus’ global growth strategy,” said Petar Vazharov, CEO of Lotus. “By combining Alvotech’s integrated biosimilar development and manufacturing capabilities with Alvogen’s established U.S. commercial platform and Lotus’s deep market presence across Asia, we are building a strong foundation for the future commercialization of … AVT87 across key global markets.”
Name-brand Hemlibra is marketed by Genentech, a subsidiary of Roche.
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