Alvotech and Lotus Pharmaceutical sign biosimilar deal worth up to $150m
Alvotech has entered into a licensing and commercialisation agreement with Taiwan-listed Lotus Pharmaceutical covering two late-pipeline biosimilar candidates: AVT34, a proposed biosimilar to AstraZeneca's cancer immunotherapy durvalumab (Imfinzi), and AVT87, a proposed biosimilar to Roche's haemophilia A therapy emicizumab (Hemlibra). The deal spans the United States and eight Asian markets, with a potential value to Alvotech of up to $150 million in upfront and milestone payments, plus ongoing supply revenues.
The reference products together generated approximately $11.9 billion in global sales in 2025, underlining the commercial scale Alvotech is targeting. Durvalumab recorded around $6.1 billion in AstraZeneca's 2025 annual filing, while emicizumab contributed roughly CHF 4.8 billion (approximately $5.8 billion) to Roche's results in the same period.
Structure of the deal
The US arrangement is semi-exclusive. Alvotech retains the right to commercialise both products directly, alongside Lotus's wholly owned US subsidiary Alvogen. Alvotech will remain the sole manufacturer and will hold responsibility for obtaining and maintaining marketing authorisations in the United States. In Asia, Lotus receives exclusive rights across South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia, and will handle local regulatory submissions and commercialisation in those territories.
Lisa Graver, chief executive of Alvotech, described the arrangement as a strategic shift: "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."
Market context
The agreement reflects a broader maturation in the biosimilar sector, where manufacturers with strong in-house development and fill-finish capabilities are increasingly seeking to capture a share of commercial economics rather than operating purely as contract developers. Alvotech already markets five biosimilars globally, including biosimilars to adalimumab, ustekinumab and aflibercept, giving it an established commercial and regulatory infrastructure upon which AVT34 and AVT87 can build.
The US biosimilar market has grown rapidly since the Biologics Price Competition and Innovation Act created the regulatory pathway, but competition in the oncology checkpoint-inhibitor space is intensifying, with several manufacturers eyeing the PD-L1 segment as durvalumab's exclusivity position evolves. Emicizumab's bispecific antibody structure presents a more complex biosimilar development challenge, which may limit the number of viable entrants and could support stronger pricing for early-to-market players.
Lotus brings Alvogen's US commercial infrastructure to the partnership, a capability that removes a significant operational barrier for Alvotech's first direct US commercial participation. The eight Asian markets named in the agreement collectively represent a substantial and growing biologics opportunity, with regulatory agencies in South Korea and Taiwan in particular having developed well-structured biosimilar approval pathways in recent years.
Neither company disclosed the individual milestone payment structure, the current regulatory status of either candidate, nor a projected launch timeline for either the US or Asian markets. Investors and analysts will be watching for IND or BLA-stage updates on AVT34 and AVT87 as the primary near-term value inflection points for this agreement.