mAbxience, Sandoz Partner on Emicizumab Biosimilar Deal

Spain-based mAbxience, a majority-owned company of Fresenius with partial ownership from Insud Pharma, and Sandoz have entered into a licensing, development, manufacturing, and commercialization agreement for a proposed biosimilar candidate referencing emicizumab (Hemlibra; Roche), used to treat hemophilia A, the companies announced September 18, 2026.¹

Under the agreement, mAbxience will be responsible for development and manufacturing through its good manufacturing practice (GMP)-approved facilities in Spain and Argentina, while Sandoz will hold exclusive commercialization rights globally, excluding Argentina, Uruguay, and Paraguay. Financial terms of the deal were not disclosed.¹

"This agreement with Sandoz represents a significant recognition of mAbxience's development and manufacturing platform and the expertise of our teams," said Jurgen Van Broeck, CEO of mAbxience, in a company press release.¹ "This agreement combines our capabilities with Sandoz's global biosimilars reach and provides a clear pathway to broaden access to treatment for patients living with hemophilia A."

Why is hemophilia A significant, and what does emicizumab do?

Hemophilia A is a rare genetic disorder caused by insufficient or defective factor VIII, a key blood-clotting protein, and accounts for approximately 80% of all hemophilia cases worldwide, representing a significant unmet medical need.¹ Emicizumab is a bispecific antibody that bridges activated factor IX and factor X to restore blood clotting function, administered subcutaneously as an alternative to traditional intravenous factor VIII replacement therapy.²

The reference product, Hemlibra, was first approved by the FDA in 2017 for patients with factor VIII inhibitors and expanded in 2018 to all patients regardless of inhibitor status, based on the phase 3 HAVEN 3 (NCT02847637) and HAVEN 4 trials, in which weekly Hemlibra prophylaxis reduced annualized bleed rates by 96% compared with no prophylaxis.²^,³ The proposed biosimilar references a global market estimated at approximately $5.7 billion, according to mAbxience.¹

What are the terms of the collaboration?

mAbxience will lead development and manufacturing of the biosimilar candidate at its GMP-approved facilities in Spain and Argentina, which have received regulatory clearance from authorities including FDA and the European Medicines Agency.¹ Sandoz will hold exclusive global commercialization rights outside Argentina, Uruguay, and Paraguay, leveraging its strong position in affordable medicines to broaden patient access.¹ The deal reflects the growing attractiveness of mAbxience's development and manufacturing platform as healthcare systems prepare for a significant wave of biologic medicines losing exclusivity over the coming years.¹

How does this fit into mAbxience's broader biosimilars strategy?

The proposed emicizumab biosimilar would expand mAbxience's pipeline into hemophilia A and strengthen its presence in rare diseases, complementing an existing biosimilar pipeline spanning oncology, immunology, bone diseases, and other specialty care areas. The company has 3 approved products and a team of more than 1300 professionals across 3 multi-product manufacturing facilities in Europe and South America.¹ The company also operates a contract development and manufacturing organization business that serves external biopharmaceutical clients.¹

What are the limitations?

The biosimilar candidate is in the development stage, and no clinical trial data, regulatory filing timeline, or specific approval pathway were disclosed. Financial terms of the agreement remain confidential, and biosimilar approval is contingent on demonstrating comparability to the reference product in future clinical studies.

References

1. mAbxience. mAbxience and Sandoz sign a collaboration agreement to advance biosimilar access worldwide. Press release. Published September 18, 2026. Accessed September 18, 2026. https://mabxience.com/mabxience-and-sandoz-sign-a-collaboration-agreement-to-advance-biosimilar-access-worldwide/
2. FDA. FDA approves emicizumab-kxwh for hemophilia A with or without factor VIII inhibitors. Published October 4, 2018. Accessed September 18, 2026. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-emicizumab-kxwh-hemophilia-or-without-factor-viii-inhibitors
3. A clinical trial to evaluate prophylactic emicizumab versus no prophylaxis in hemophilia A participants without inhibitors (HAVEN 3). ClinicalTrials.gov; NCT02847637. Updated November 16, 2022. Accessed September 18, 2026. https://clinicaltrials.gov/study/NCT02847637