Hospira and STADA's Biosimilar Epoetin Retacrit Receives Positive Opinion Recommending EU Approval

Hospira (Lake Forest, IL) has received a "positive opinion" recommending European Union (EU) approval for its biosimilar Retacrit (epoetin zeta), a treatment for anemia associated with chronic renal failure and chemotherapy-induced anemia. Retacrit is a similar biologic, often referred to as a biosimilar or a biogeneric, to epoetin alfa.

The Committee for Medicinal Products for Human Use (CHMP) issued the positive opinion, and the European Commission, which approves pharmaceuticals for use in Europe, usually follows CHMP recommendations. Hospira expects EU approval for Retacrit in late 2007. The company plans to launch the product, Hospira's first marketed similar biologic, in various EU countries beginning in early 2008.

In late 2006, Hospira, STADA Arzneimittel AG (Bad Vilbel, Germany), and BIOCEUTICALS Arzneimittel AG (Bad Vilbel, Germany) announced development, manufacturing, and distribution agreements for epoetin zeta. Under these agreements, Hospira obtained exclusive distribution rights for the product in countries including the US and much of Europe, with the exception of Germany, where Hospira and STADA will both market the product. The epoetin zeta project is being pursued through BIOCEUTICALS, a company spun out of STADA. STADA controlled the development process and conducted the approval process on behalf of BIOCEUTICALS and Hospira. Hospira has significantly invested in expanding to develop, manufacture, and market similar biologics.

Hospira release

STADA release