Hospira, a leading global hospital products company, has received a "positive opinion" recommending European Union (EU) approval for Retacrit (epoetin zeta)
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness(TM) by developing, manufacturing and marketing products that help improve the productivity, safety and efficacy of patient care. The company has received a "positive opinion" recommending European Union (EU) approval for 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" in Europe or "biogeneric" in the United States — to epoetin alfa.
The Committee for Medicinal Products for Human Use (CHMP) issued the positive opinion; and the European Commission, which approves pharmaceuticals, usually follows CHMP recommendations. Hospira expects EU approval for Retacrit in late 2007. The company plans to launch the product — which will be Hospira's first marketed similar biologic — in various EU countries beginning in early 2008.
Biopharmaceuticals, or biologics, are large-protein molecules derived from genetically modified cell lines. A growing number of proprietary biopharmaceuticals' patents are expiring; and similar biologics are opening a large, emerging market. Hospira has significantly invested in expanding its comprehensive competencies to develop, manufacture and market similar biologics. The European Commission approves similar biologics that demonstrate quality, efficacy and safety that are similar to currently available biopharmaceuticals in the approved indications. It has already approved other similar biologics. A comparable legal and regulatory approval pathway does not yet exist in the United States.