mAbxience and Sandoz have entered into a license, development, manufacturing and marketing agreement for a planned Emicizumab biosimilar candidate, combining mAbxience's development and production capabilities with Sandoz's global commercial reach.
Under the agreement, mAbxience will develop and manufacture the biosimilar at its GMP-certified facilities in Spain and Argentina. Sandoz will hold exclusive worldwide marketing rights, excluding Argentina, Uruguay and Paraguay. Financial terms were not disclosed.
mAbxience is majority-owned by Fresenius SE & Co. KGaA (XETR: FRE; OTCM: FSNUY), with Insud Pharma holding a minority stake. Sandoz trades on the SIX Swiss Exchange (SDZ) and OTCQX (SDZNY).
Emicizumab is a proposed biosimilar based on Roche's Hemlibra, indicated for the treatment of hemophilia A. The global reference market for Emicizumab is estimated at approximately $5.7 billion. Hemophilia A, caused by a deficiency or malfunction of factor VIII, a key blood-clotting protein, accounts for roughly 80% of all hemophilia cases worldwide and continues to represent significant unmet medical need for patients and health systems.
The partnership aligns with mAbxience's strategy of expanding patient access to high-quality biologics through targeted commercial collaborations on global markets. The planned Emicizumab biosimilar expands mAbxience's pipeline in hemophilia A and strengthens its presence in rare diseases. It adds to the company's growing biosimilar portfolio, which spans oncology, immunology, bone disease and other specialty areas.
"This agreement with Sandoz is a significant recognition of mAbxience's development and production platform as well as the expertise of our teams," said Jürgen Van Broeck, CEO of mAbxience. "It combines our competencies with Sandoz's global reach in biosimilars and paves the way for broader access to treatment for patients with hemophilia A."
The deal underscores the growing attractiveness of mAbxience's platform as health systems prepare for a substantial wave of biologics whose exclusivity expires over the coming years.
