mAbxience and Sandoz have signed a licensing, development, manufacturing and commercialization agreement for a proposed biosimilar version of emicizumab, a treatment used for hemophilia A.
Under the agreement, mAbxience will develop and manufacture the candidate biosimilar at its good manufacturing practice-approved facilities in Spain and Argentina. Sandoz will receive exclusive commercialization rights worldwide, excluding Argentina, Uruguay and Paraguay. The companies did not disclose financial terms.
The proposed medicine would reference Hemlibra, Roche’s emicizumab product. mAbxience said the reference product has an estimated global market of approximately $5.7 billion.
Hemophilia A is a genetic bleeding disorder caused by insufficient or defective factor VIII, a blood-clotting protein. It accounts for about 80% of hemophilia cases, according to the companies.
The deal expands mAbxience’s biosimilar pipeline into hemophilia A and other rare-disease areas. mAbxience is majority owned by Fresenius SE & Co. KGaA, with Insud Pharma holding a partial ownership stake. Sandoz is a producer of generic and biosimilar medicines.
The companies did not disclose the development stage of the emicizumab biosimilar candidate, a timetable for clinical trials, regulatory submissions or potential launch dates. They also did not specify the financial structure of the agreement, including upfront payments, milestone payments, royalties or how development costs will be shared.
The agreement gives mAbxience responsibility for technical development and production while assigning commercial responsibility in most markets to Sandoz. Both companies said the collaboration is intended to support wider access to an emicizumab biosimilar if it is developed and approved.