mAbxience and Sandoz Sign a Collaboration Agreement to Advance Biosimilar Access Worldwide

• mAbxience and Sandoz have entered into a collaboration agreement combining mAbxience's development and manufacturing expertise with Sandoz's global commercial capabilities for a proposed emicizumab biosimilar candidate.
• Emicizumab biosimilar expands mAbxience's pipeline into haemophilia A and strengthens its presence in rare diseases.
• The agreement is consistent with mAbxience's strategy of broadening patient access to high-quality biologic medicines through selected partnerships in global markets.

MADRID, Sept. 18, 2026 /PRNewswire/ -- mAbxience, a majority-owned company of Fresenius SE & Co. KGaA (XETR: FRE) (OTCM: FSNUY) with partial ownership from Insud Pharma; and Sandoz (SIX: SDZ) (OTCQX: SDZNY), the global leader in affordable medicines, today announced a licensing, development, manufacturing and commercialization agreement for an emicizumab biosimilar candidate. The collaboration agreement combines mAbxience's proven development and manufacturing capabilities with Sandoz's global commercial reach, creating a pathway to broaden patient access to this potential high-quality biologic medicine worldwide.

Under the terms of the agreement, mAbxience will be responsible for the development and manufacturing of the agreed biosimilar through its state-of-the-art GMP-approved facilities in Spain and Argentina, while Sandoz will hold exclusive commercialization rights globally, excluding Argentina, Uruguay, and Paraguay. The financial terms of the agreement remain confidential. The agreement highlights 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.

Emicizumab is a proposed biosimilar candidate development referencing Hemlibra^® (emicizumab), and is indicated for the treatment of hemophilia A and represents an estimated global reference market of approximately USD 5.7 billion.

Hemophilia A is a rare genetic disorder caused by insufficient or defective factor VIII, a key blood-clotting protein. As the most common form of hemophilia, it accounts for around 80% of all cases worldwide and continues to represent a significant unmet medical need for patients and healthcare systems.

Jurgen Van Broeck, Chief Executive Officer of mAbxience, said: "This agreement with Sandoz represents a significant recognition of mAbxience's development and manufacturing platform and the expertise of our teams. 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. It also reinforces our strategy of combining world-class development and manufacturing capabilities with selected commercial partnerships that can help accelerate patient access to high-quality biologic medicines worldwide."

The agreement further reinforces mAbxience's position as a global leader in biosimilars with development and manufacturing capabilities across complex biologics. The proposed emicizumab biosimilar candidate would expand mAbxience's presence in rare diseases and complement its growing biosimilar pipeline, which spans oncology, immunology, bone diseases, and other specialty care areas.