mAbxience, Sandoz to Collaborate on Emicizumab Biosimilar Candidate

Editor’s Take: Biosimilar development is crucial in preparing for a wave of medicines losing exclusive status in coming years.

mAbxience and Sandoz announced a license, development, manufacturing, and commercial agreement for an emicizumab biosimilar candidate. This references Genentech’s Hemlibra (emicizumab), a subcutaneous injection for treatment of hemophilia A.

Importance of Emicizumab

A rare genetic disorder, hemophilia A stems from poor factor VIII—a key protein in blood clotting. It is the most common form of hemophilia, accounting for approximately 80% of worldwide cases.

However, it remains a significant unmet medical need, and the global reference market is estimated at approximately $5.7 billion.

The agreement tasks mAbxience with development and manufacturing via its state of the art, good manufacturing practice (GMP)-approved facilities in Spain and Argentina. Sandoz holds exclusive, global commercial rights, save for Argentina, Uruguay, and Paraguay.

mAbxience and Sandoz Agree on Impact

Both sides say their pact cuts off a coming wave of biologic medicines losing exclusivity in the next several years.

“This agreement with Sandoz represents a significant recognition of mAbxience’s development and manufacturing platform,” mAbxience CEO Jurgen Van Broeck said. “[It] 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.”

The goal, Van Broeck says, is speeding up worldwide patient access to high quality biologic medicines.

Furthermore, mAbxience believes Sandoz’ global biosimilars reach will reinforce its own position in the field.

mAbxience’s current pipeline includes oncology, immunology, bone diseases, and other areas of special care.

Exact financial terms of the mAbxience–Sandoz agreement remain private at this time.