12:00 AM
Apr 15, 2002
 |  BioCentury  |  Regulation

Opening an EPO Front in Europe

Countdown to Biogenerics

Opening an EPO Front in Europe

While hGH and urokinase are likely to be the flashpoints for the U.S. debate on biogenerics, in Europe the first struggle could be over the blockbuster erythropoietin market. At least six companies hope to launch biogeneric EPO in Europe in 2004 or 2005, and several told BioCentury that they have received indications from European regulators that it may be possible to obtain approval based on an abbreviated set of clinical trials.

For example, Dragon Pharmaceuticals Inc. (DRUG, Vancouver, B.C.) has had preliminary discussions with EU regulators about requirements for selling its EPO in Europe and "it is definitely our understanding that trial [requirements] will be abbreviated in Europe," said Rita Jervis, vice president of corporate development.

DRUG expects that its EPO will be completely interchangeable with Amgen Inc.'s Epogen, she said.

The situation in Europe is somewhat different from that in the U.S. Several biologics come off patent earlier than in the U.S. In addition, European patent holders cannot follow a strategy of making modifications to the drug to prolong patent life. Hence in Europe, follow-on companies can prepare for an earlier and more reliable start of biogenerics sales.

On the downside, biologics in the EU only can be approved by the EMEA, and the agency has not yet issued clear guidance about the requirements for an admission.

There is, however, a guideline on the comparability of biologics products. The Note for Guidance CPMP/BWP/3207/00 is requesting studies demonstrating quality, safety and efficacy if the manufacturing process of a recombinant protein already on the market is changed. Such studies may include new Phase I and III trials, and the European generics industry anticipates that similar rules will apply to biogenerics.

"Compared to ordinary generics, the situation is quite different, and both manufacturers and the regulatory authorities are treading on new ground," said Elmar Schäfer, CEO of BioGeneriX AG (Mannheim, Germany), a 100% subsidiary of ratiopharm GmbH (Ulm, Germany), the biggest generics company in Germany. BioGeneriX was founded in June 2000 to supply ratiopharm and other international distributors with generic biopharmaceuticals.

"With biogenerics, it is difficult to simply refer to biological equivalence, as in the case of recombinant proteins the process is the product," Schäfer said. "We...

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