- Approval and Launch of Hospira's First Similar Biologic Expected by Early
LAKE FOREST, Ill., Oct. 19 /PRNewswire-FirstCall/ -- Hospira (NYSE: HSP), a leading global hospital products company, announced today that it 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.
"As the world leader in generic injectables, Hospira is ready to bring high-quality, lower-cost similar biologics to patients. We are pleased to have crossed this milestone for this important medication," says Michael Kotsanis, president, Europe, Middle East and Africa, Hospira. "Similar biologics like Retacrit can help provide safe, effective patient care while helping to reduce global healthcare costs."
In late 2006 Hospira; STADA Arzneimittel AG; and BIOCEUTICALS
Arzneimittel AG, a STADA-initiated company, announced development,
manufacturing and distribution agreements for epoetin zeta. Under these
agreements, Hospira obtained exclusive distribution rights for the product
in countries including the United States 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. STADA
controlled the development process and conducted the approval process on
|SOURCE Hospira, Inc.|
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