- Agreement for emicizumab biosimilar in reference market worth USD 5.7 billion; marks first haemophilia biosimilar in pipeline
- Provides basis for evaluating potential future collaboration opportunities based on shared commitment to expanding access to biosimilar medicines
- Strengthens Sandoz position in biosimilars and further expands industry-leading pipeline to 40 assets; continues momentum following agreements with Henlius and Samsung Bioepis
- Reinforces commitment to expand patient access by capturing significant share of unprecedented upcoming biosimilar loss-of-exclusivity market opportunity
Basel, 18 September 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announces a licensing, development, manufacturing and commercialisation agreement with mAbxience, marking another significant step to broaden patient access to high-quality biosimilar medicines worldwide.
The agreement paves the way for the two companies to collaborate on a proposed emicizumab biosimilar, currently in early-stage development. The reference medicine, Hemlibra®* (emicizumab), is used to treat patients with haemophilia A1,2, making emicizumab the first haemophilia medicine in the Sandoz biosimilar pipeline. The reference medicine market is worth an estimated USD 5.7 billion in global sales.3
Richard Saynor, Chief Executive Officer, Sandoz, says: “This agreement with mAbxience reflects our continued commitment to our Purpose of pioneering access for patients. The addition of emicizumab strengthens our pipeline and expands our presence in rare diseases, an area where we believe biosimilars can play an important role in addressing unmet patient needs while supporting the long-term sustainability of healthcare systems in the face of rising treatment costs.”
Haemophilia A is a rare genetic disorder caused by inadequate or defective factor VIII (FVIII), ablood-clotting protein, which causes prolonged bleeding in patients4. It is the most common form of haemophilia, accounting for approximately 80% of all cases5, with more than half of patients having a severe form of the disease6.
Under the terms of the agreement, Sandoz will have exclusive global commercialisation rights for the proposed emicizumab biosimilar, excluding Argentina, Uruguay and Paraguay, while mAbxience will be responsible for development and manufacturing. Both parties have agreed to keep the financial terms of the agreement confidential. The agreement also provides a basis for the two companies to evaluate potential future collaboration opportunities based on their shared commitment to expanding patient access to biosimilar medicines around the world.
Overall, the collaboration expands the industry-leading Sandoz biosimilar pipeline to 40 assets and builds on the earlier agreements with Henlius for up to 10 assets and Samsung Bioepis for up to five assets. It also represents another milestone in the Company’s strategy to capture a significant share of the unprecedented upcoming biosimilar loss-of-exclusivity market. Sandoz continues to build on its experience as the pioneer and global leader with a portfolio of 13 molecules available in nearly 100 countries.
*Hemlibra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha.
DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.
REFERENCES
1 European Medicines Agency (EMA). Hemlibra. Product Information. Available at: Hemlibra, INN-emicizumab. [Last accessed September 2026]
2 US Food and Drug Administration (FDA). Hemlibra. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761083s020lbl.pdf. [Last accessed September 2026]
3 Roche Finance Report. 2025. Available at: Roche Finance Report 2025. [Last accessed September 2026]. CHF to USD conversion performed by Sandoz. Data on file.
4 World Federation of Hemophilia (WFH). Hemophilia. Available at: https://elearning.wfh.org/elearning-centres/hemophilia/. [Last accessed September 2026]
5 Merck Manual Professional Version. Hemophilia. Available at: https://www.merckmanuals.com/professional/hematology-and-oncology/coagulation-disorders/hemophilia. [Last accessed September 2026]
6 National Bleeding Disorders Foundation (NBDF). Hemophilia A. Available at: https://www.bleeding.org/bleeding-disorders-a-z/types/hemophilia-a. [Last accessed September 2026]
ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. In 2025, Sandoz recorded net sales of USD 11.1 billion.
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