Sandoz has entered into a collaboration with mAbxience to develop and commercialise a proposed biosimilar referencing Hemlibra (emicizumab), marking the Swiss drugmaker's entry into biosimilar treatments for rare blood disorders.
The agreement targets a global reference market estimated at $5.7 billion (£4.27 billion) in annual sales. Emicizumab is indicated for haemophilia A - a rare inherited bleeding disorder caused by deficient or dysfunctional factor VIII clotting protein, which represents about 80% of all haemophilia cases globally.
Under the terms of the agreement, mAbxience (a majority-owned subsidiary of Fresenius) will lead development and manufacturing across its certified GMP production facilities in Spain and Argentina.
In turn, Sandoz gets exclusive global commercialisation rights, excluding three South American markets: Argentina, Uruguay, and Paraguay. The financial terms of the deal were not disclosed.
The partnership marks the 40th asset in the Sandoz biosimilar pipeline, reinforcing its aggressive build up following multi-product agreements with Henlius (up to 10 assets) and Samsung Bioepis (up to five assets).
Sandoz Chief Executive Officer Richard Saynor said: “This agreement with mAbxience reflects our continued commitment to our Purpose of pioneering access for patients.
“The addition of emicizumab strengthens our pipeline and expands our presence in rare diseases, an area where we believe biosimilars can play an important role in addressing unmet patient needs while supporting the long-term sustainability of healthcare systems in the face of rising treatment costs.”
