mAbxience and Sandoz have signed a collaboration agreement covering the licensing, development, manufacturing and commercialization of a proposed emicizumab biosimilar candidate. mAbxience, majority-owned by Fresenius SE & Co. KGaA with partial ownership from Insud Pharma, will handle development and manufacturing through its GMP-approved facilities in Spain and Argentina. Sandoz will hold exclusive global commercialization rights, excluding Argentina, Uruguay and Paraguay. Financial terms were not disclosed.
Emicizumab is a biosimilar candidate referencing Hemlibra, indicated for the treatment of hemophilia A — the most common form of hemophilia, accounting for roughly 80% of cases worldwide. The condition stems from insufficient or defective factor VIII, a key blood-clotting protein. The global reference market for emicizumab is estimated at approximately USD 5.7 billion.
Jurgen Van Broeck, CEO of mAbxience, said the deal represents a recognition of the company's development and manufacturing platform and expertise. "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," he said.
The collaboration expands mAbxience's pipeline into haemophilia A and strengthens its presence in rare diseases. It complements the company's growing biosimilar portfolio spanning oncology, immunology, bone diseases and other specialty care areas.
The agreement aligns with mAbxience's strategy of broadening patient access to high-quality biologic medicines through selected partnerships in global markets. It also underscores the growing relevance of mAbxience's development and manufacturing platform as healthcare systems prepare for a significant wave of biologic medicines losing exclusivity over the coming years.
