- mAbxience and Sandoz have signed an agreement covering the development, manufacturing and commercialization of an emicizumab biosimilar candidate for hemophilia A.
- mAbxience will develop and manufacture the biosimilar in Spain and Argentina, while Sandoz will hold exclusive global commercialization rights, excluding Argentina, Uruguay and Paraguay.
mAbxience and Sandoz have entered into a licensing, development, manufacturing and commercialization agreement for an emicizumab biosimilar candidate intended for the treatment of hemophilia A. The agreement combines mAbxience’s development and manufacturing capabilities with Sandoz’s global commercialization network.
Under the agreement, mAbxience will be responsible for developing and manufacturing the biosimilar at its GMP-approved facilities in Spain and Argentina. Sandoz will hold exclusive commercialization rights worldwide, excluding Argentina, Uruguay and Paraguay. The financial terms were not disclosed.
The proposed biosimilar references Hemlibra® (emicizumab), which is indicated for the treatment of hemophilia A. The press release estimates the global reference market for emicizumab at approximately $5.7 billion. Hemophilia A is a rare genetic disorder caused by insufficient or defective factor VIII, a blood-clotting protein, and accounts for around 80% of hemophilia cases worldwide.
The collaboration will also expand mAbxience’s presence in rare diseases and complement its biosimilar pipeline, which covers oncology, immunology, bone diseases and other specialty care areas. The company said the agreement reflects the growing attractiveness of its development and manufacturing platform as healthcare systems prepare for biologic medicines losing exclusivity in the coming years.
“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.”
Jurgen Van Broeck, Chief Executive Officer of mAbxience
