Genzyme path signals tough road for U.S. biogenerics

By Susan Heavey Friday, October 31, 2008; 1:27 PM

WASHINGTON (Reuters) - U.S. regulatory scrutiny over the manufacturing of a Genzyme Corpdrug signals steep hurdles that could await future generic versions of complex biotech medicines.

U.S. lawmakers are expected to allow cheaper, copycat alternatives for protein-based biologics as soon as next year, but how much proof the Food and Drug Administration will require to show they work as well as the original products remains an open question.

The case of Genzyme's Myozyme could set a precedent, analysts said, even though Myozyme, which treats a rare enzyme disorder, is not a generic drug.

Last week, the FDA took an unusual step in convening an advisory panel simply to review the Cambridge, Massachusetts-based company's request to boost production capacity. Myozyme won approval in 2006, but has been produced only at a smaller facility.

At the panel meeting, the agency raised questions about the product's consistency, and FDA advisers suggested that Genzyme conduct additional clinical studies to satisfy those concerns.

"If this company, which is highly experienced in making protein therapeutics... has to go through this enormous effort to get approval for the second product -- that has to have a chilling effect upon the viability of biosimilars for many therapeutic proteins," Geoffrey Porges, a senior analyst for Bernstein Research, told Reuters.

Unlike traditional chemical drugs, biologic drugs are derived from proteins and most are not currently allowed to be reproduced by generic drugmakers. They treat conditions such as cancer, anemia, psoriasis, and arthritis, among others.

Their complex manufacturing is reflected in their price, with brand-name versions costing tens of thousands of dollars a year. As a result, lawmakers, health insurers and some consumer advocates are eager to see cheaper versions on the market.

Until recently, brand-name manufacturers objected to allowing generic makers to reproduce their drugs, saying the complicated manufacturing process made it impossible to make an identical product.

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