Hospira, Stada Arzneimittel AG, and Bioceuticals Arzneimittel AG, a Stada-initiated company focused on biosimilar products, have entered into a development, manufacturing and distribution agreements for a generic version of erythropoietin (EPO). Erythropoietin is a naturally occurring protein hormone produced by the kidney. Therapeutic erythropoietin is used to treat anemia in dialysis and in certain oncology applications.

“Developing and providing access to biosimilars is a natural extension of Hospira’s leadership position in generic injectable pharmaceuticals and an important part of our strategy of investing for growth,” said Christopher B. Begley, chief executive officer, Hospira. “The collaboration will help expand the availability of a more cost-effective alternative to EPO medications currently on the market, furthering our ability to take additional costs out of the global healthcare system.”

Through the agreement, Hospira obtains exclusive distribution rights for Bioceuticals’ erythropoietin in the EU and several other European countries. Hospira will retain exclusive distribution rights in the U.S. and Canada, where it will also be responsible for the development and manufacture of the product. Hospira holds a first right of refusal for the distribution rights in all other countries. Bioceuticals will receive a $21 million upfront payment, as much as an additional $34 million in payments based on meeting specified objectives, and royalty payments on commercial sales.

Bioceuticals has submitted a marketing application for a biosimilar erythropoietin to the EMEA for a dialysis indication. The company is currently conducting trials in support of an oncology indication. Due to later patent expirations, a U.S. launch of the product is not expected for several years.