Sandoz and Fresenius-Owned mAbxience Sign Global Licensing and Manufacturing Collaboration for Emicizumab Biosimilar Candidate; Targets Roche Hemlibra's ~$5.7 Billion Hemophilia A Market
Sandoz Group (SIX: SDZ) and mAbxience (majority-owned by Fresenius SE & Co. KGaA) announced Friday September 18, 2026 a licensing, development, manufacturing, and commercialization agreement for a biosimilar candidate of emicizumab, the bispecific factor IXa/factor X monoclonal antibody currently marketed by Roche as Hemlibra for hemophilia A. The reference product (Hemlibra) generated approximately $5.7 billion in global 2025 sales and is Roche's largest hemophilia franchise product. Under the agreement, mAbxience will develop and manufacture the biosimilar at 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. This is Sandoz's first entry into the hemophilia biosimilar space and expands mAbxience's pipeline from oncology (rituximab, bevacizumab, trastuzumab biosimilars) and immunology into rare-disease bleeding disorders. Hemlibra composition patents run through 2029-2032 in major markets; biosimilar launch timing will depend on both regulatory approval and patent-cliff sequencing.