Alvotech and Lotus sign $150m biosimilar deal for two biologics
Alvotech has struck a licensing and commercialisation agreement with Taiwan-listed Lotus Pharmaceutical covering two biosimilar candidates, AVT34 (proposed biosimilar to AstraZeneca's durvalumab) and AVT87 (proposed biosimilar to Roche's emicizumab), in the United States and eight Asian markets. The deal carries a potential value to Alvotech of up to approximately $150 million in upfront and milestone payments, plus ongoing revenues from product supply.
The arrangement is structured as semi-exclusive in the US, where Alvotech retains the right to commercialise both products directly alongside Lotus, which will operate through Alvogen, its US-based wholly owned subsidiary. Alvotech remains solely responsible for product development, regulatory authorisations and supply. In Asia, Lotus holds exclusive rights in South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia, and will handle local regulatory submissions in those markets.
Strategic context
Lisa Graver, chief executive of Alvotech, described the deal as a meaningful shift in how the company participates commercially in the United States. "For the first time, we will have the opportunity to participate directly in the future commercialisation 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," she said.
The reference products are significant in scale. Durvalumab, marketed as Imfinzi by AstraZeneca, generated approximately $6.1 billion in global sales in 2025 across its approved oncology indications, which include non-small cell lung cancer, biliary tract cancer and hepatocellular carcinoma. Emicizumab, marketed as Hemlibra by Roche, recorded approximately CHF 4.8 billion (roughly $5.8 billion) in global sales in 2025, where it is used as routine prophylaxis in haemophilia A.
Market landscape and regulatory read-across
The biosimilar market for high-value oncology and haematology biologics remains one of the more competitive development arenas in the sector. Entry barriers are meaningful: large-molecule complexity, substantial analytical comparability requirements, and the need for clinical bridging data all lengthen the path to approval relative to small-molecule generics. Durvalumab's patent estate is an active area of industry attention, and the timing of any potential biosimilar market entry will depend on both Alvotech's regulatory submissions and the outcome of intellectual property proceedings.
Emicizumab is a bispecific antibody with a distinctive mechanism, mimicking the function of factor VIIIa, which makes demonstrating biosimilarity technically demanding. The FDA has approved bispecifics as reference products before, but the analytical and clinical package required is extensive. No approval timelines or IND filing dates were disclosed for either AVT34 or AVT87.
Alvotech already has five biosimilars approved and on the market globally, including products referencing adalimumab, ustekinumab and aflibercept, which gives the company an established manufacturing and regulatory track record to draw on. Investors will focus on whether Alvotech can replicate that execution on two technically more complex reference molecules, and on the near-term milestone payment schedule underpinning the $150 million headline figure.