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12:00 AM
 | 
Oct 22, 2007
 |  BioCentury  |  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 products, EMEA's approval of a biosimilar epoetin alfa from Novartis AG subsidiary Sandoz provides a concrete example of the difference between approval standards for a biosimilar product and a pioneer.

It also highlights the increasing regulatory burden on new innovators, which clearly are being asked to conduct more complex clinical studies as the follow-on biologics are reaching the market with abbreviated data packages.

Indeed, comparisons of the Sandoz development program with those conducted to support approval of follow-on innovators show how high the bar has gotten for erythropoiesis-stimulating agents over the two decades since the first ESA was first tested in humans.

While Sandoz did less clinical research on its copycat product than Amgen Inc. conducted to gain FDA approval for Epogen epoetin alfa in 1989, the difference is small compared to the gap between the original approval requirements and the amount of data regulators on both sides of the Atlantic are imposing on manufacturers of newer drugs in the class (see "ESAs Then & Now," A13). ...

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