Two major strategic collaborations announced in July and August 2026 underscore the intensifying race to capture value from the upcoming biosimilar wave, as Sandoz broadens its industry-leading portfolio and Teva strengthens its pipeline through a key licensing agreement.
Sandoz–Henlius: 10‑asset biosimilar pact
On 17 August 2026, Sandoz announced a strategic collaboration with Shanghai Henlius Biotech covering up to 10 proposed monoclonal antibody and antibody-drug conjugate biosimilar assets. The agreement represents one of the largest biosimilar collaborations for Sandoz and expands its pipeline to 39 assets, with potential to reach 46.
Under the terms, Henlius grants Sandoz exclusive global commercialization rights outside China, while Henlius remains responsible for development, manufacturing and supply. The deal is milestones-based with total consideration up to US$322 million, including near-term payments for initial assets that could reach US$100.5 million.
The initial assets include HLX05‑N, a proposed cetuximab biosimilar (reference: Erbitux®) for metastatic colorectal cancer and head and neck squamous cell carcinoma; HLX16, a proposed evolocumab biosimilar for hypercholesterolaemia; and a proposed belimumab biosimilar for systemic lupus erythematosus and lupus nephritis. Sandoz also obtained an option for HLXTE‑HAase1001, a recombinant human hyaluronidase for subcutaneous administration.
Beyond these pipeline assets, Henlius has already demonstrated its regulatory capability with three biosimilars approved in Europe in 2025 and 2026: two denosumab products (Bildyos and Bilprevda) and a pertuzumab biosimilar (Poherdy) [1]. Bildyos and Bilprevda (denosumab-nxxp) and Poherdy (pertuzumab-dpzb) are also approved in the US (2025) [2, 3], alongside Hercessi (trastuzumab-strf), a trastuzumab biosimilar approved in 2024.
The agreement builds on an existing partnership established in April 2025 for HLX13, Henlius' proposed ipilimumab biosimilar.
Teva–Polpharma: ocrelizumab biosimilar license
Separately, on 9 July 2026, Teva Pharmaceutical and Polpharma Biologics announced a global licensing agreement granting Teva exclusive rights to commercialize a proposed biosimilar to Ocrevus® (ocrelizumab) for multiple sclerosis.
The agreement covers both intravenous and subcutaneous formulations. Polpharma retains full responsibility for development and manufacturing, while Teva will handle regulatory submissions and, upon approval, commercialisation across Australia, Brazil, Canada, Europe, Israel, New Zealand, Turkey, and the US.
Ocrelizumab is a humanized monoclonal antibody targeting CD20‑positive B cells. The reference product, developed by Genentech/Roche, is approved for relapsing and primary progressive MS. Ocrevus generated CHF 7.6 billion in global sales in 2025. The US primary patent is expected to expire after October 2028, with market exclusivity running through March 2029.
The Teva‑Polpharma agreement positions Teva as a key contender in what is shaping up to be a multi‑company race toward the first approved ocrelizumab biosimilar, with Amgen, Biocad, Celltrion, CinnaGen [4], and Sandoz also competing with Phase 3 ocrelizumab candidates.
Both collaborations reflect accelerating consolidation and partnership activity in the biosimilars sector, as companies position themselves to capture value from the unprecedented wave of biological patent expiries expected over the next decade.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for pertuzumab and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 2]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-pertuzumab-and-tocilizumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves six denosumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 2]. Available from: www.gabionline.net/biosimilars/news/fda-approves-six-denosumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves Poherdy (first interchangeable pertuzumab) and Armlupeg (pegfilgrastim) biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 2]. Available from: www.gabionline.net/biosimilars/news/fda-approves-poherdy-first-interchangeable-pertuzumab-and-armlupeg-pegfilgrastim-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Phase III trial results of CinnaGen’s ocrelizumab similar biotherapeutic product [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Sep 2]. Available from: www.gabionline.net/pharma-news/phase-iii-trial-results-of-cinnagen-s-ocrelizumab-similar-biotherapeutic-product
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