BioCentury

7:00 AM GMT, Oct 22, 2007
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Regulation

And then there were 5

Last week's CHMP recommendation for approval of another biosimilar erythropoietin, coming two months after EC approval of a Sandoz biosimilar EPO, sets the stage for the first real-world test of the safety and economics of biosimilars.

Assuming the EC complies with CHMP's recommendation, there will be five biosimilar brands of erythropoietin on the European market, as well as three pioneer products.

The most recent CHMP biosimilar EPO recommendation covers two applications for the same product, which was developed and is manufactured by Stada Arzneimittel AG (FSE:SAZ, Bad Vilbel, Germany) and its biosimilars spinout Bioceuticals Arzneimittel AG. Stada has co-distribution rights for Silapo epoetin zeta in Germany, while Bioceuticals has distribution rights for the entire EU.

Hospira Inc. (HSP, Lake Forest, Ill.), a manufacturer and distributor of generic injectables, has rights to distribute Stada's epoetin zeta under the trade name Retacrit in Europe outside Germany and in the U.S., where it faces an uncertain regulatory and IP environment.

While details of the data package submitted for epoetin zeta will not be released unless and until EMEA approves the

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