Alvotech and Taiwan-listed Lotus Pharmaceutical announced on Aug. 21 a licensing and commercialization agreement covering AVT34, Alvotech's proposed biosimilar to the PD-L1 antibody durvalumab (Imfinzi), and AVT87, a proposed biosimilar to emicizumab (Hemlibra). In the US the arrangement is semi-exclusive, with Alvotech selling alongside Lotus' Alvogen subsidiary, and in eight Asian markets Lotus holds exclusive rights. Alvotech said the deal could bring it up to about $150 million in upfront and milestone payments plus supply revenue.
- Products: AVT34 (proposed durvalumab biosimilar) and AVT87 (proposed emicizumab biosimilar).
- Reference-product sales: Imfinzi about $6.1 billion in 2025 per AstraZeneca's 20-F, and Hemlibra about CHF 4.8 billion (roughly $5.8 billion).
- US structure: semi-exclusive, with Alvotech commercializing directly and Lotus commercializing through Alvogen.
- Asia: Lotus exclusive in South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia, and responsible for local filings.
- Economics: up to approximately $150 million in upfront and milestones to Alvotech, plus ongoing supply revenue, with Alvotech as exclusive supplier for all markets.
- Development: Alvotech keeps responsibility for development and for obtaining and maintaining US marketing authorizations.
Alvotech sells its own product in the US for the first time
Alvotech's five marketed biosimilars, to Humira, Stelara, Simponi, Eylea and Prolia/Xgeva, have all gone to market through partners, and the company describes AVT34 and AVT87 as the first products it will commercialize itself in the US. Lotus takes exclusive rights in South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia and carries the local filings, while Alvotech keeps development, the US marketing authorizations and supply for every market in the deal. "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," said Lisa Graver, Alvotech's chief executive officer. Lotus' CEO, Petar Vazharov, said the candidates "expand the scale and reach of our biosimilar portfolio in oncology and rare diseases."
A durvalumab copy with no disclosed timeline
Alvotech describes Imfinzi as an oncology biologic used in multiple cancers and sources its $6.1 billion 2025 sales figure to AstraZeneca's annual report on Form 20-F. The release does not state AVT34's development stage, whether a comparative clinical study is under way, the expected filing date, or any patent or exclusivity dates for durvalumab, so none of that can be reported here. Nor does it describe how Alvotech and Alvogen will divide the US market under the semi-exclusive arrangement beyond the statement that both will sell. AVT87, the emicizumab candidate, is a hemophilia A prophylaxis product and sits outside oncology, and its reference product sold about CHF 4.8 billion, roughly $5.8 billion.
Why This Matters to the APO|APE Reader
A ceiling of about $150 million in upfront and milestone payments, set against a reference product that sold $6.1 billion last year, tells where Alvotech expects to make its money: in its role as exclusive manufacturer for every market in the deal, which is the part of the agreement that does not carry a cap. A durvalumab biosimilar reaching US oncology pharmacies would arrive with the PD-L1 immunohistochemistry conventions already attached to the reference product, and the release says nothing about that or about a launch year, which leaves a BLA acceptance announcement as the first practical signal for pharmacy and therapeutics committees.
