Lower status for biotech drug knockoffs?

Lower status for biotech drug knockoffs?

	Published : Fri, 16 Mar 2007 15:36 By : Agencies Print this Story

WASHINGTON (AP) - Copycat versions of pricey biotech drugs may be relegated to a status below that of generic versions of traditional chemical drugs, the head of the Food and Drug Administration suggested Thursday.

Dr. Andrew von Eschenbach told pharmaceutical executives that such knockoffs would be considered only 'similar' to brand-name drugs. The FDA commissioner later told The Associated Press that would mean knockoffs would not be interchangeable, or able to be substituted.

That definition mirrors one used by the European Medicines Agency, the FDA's European counterpart. It would draw a distinction between biotech knockoffs, which the FDA says it still lacks the legal and scientific frameworks to approve, and the generic versions of traditional drugs already available.

Today, traditional drug knockoffs or generics are identical to their brand-name versions and can be swapped or substituted for one another. That would not be the case with a knockoff biotech drug deemed only 'similar,' even though its effect on patients would be the same.

'We recognize that the end point would be what could be best described as similarity. Similarity in the sense that when a doctor gives you the product -- delivered it to a patient -- it will achieve an effect that is similar to the effect that we expected from the innovative ... compound,' von Eschenbach told the annual meeting of the Pharmaceutical Research and Manufacturers of America, the drug industry group.

Unlike traditional chemical-based drugs, biotech drugs -- also called biologics or biopharmaceuticals -- are made from proteins taken from living cells. Generally, biotech drugs are far more costly and complex than traditional drugs to both make and copy.

Because of that complexity, the FDA and the brand-name drug industry both maintain it would be difficult to ensure the safety and effectiveness of the knockoffs, sometimes called follow-on protein products.

A bipartisan group of lawmakers recently renewed the push to give the agency that legal authority. The FDA says it continues to develop the scientific guidelines required to consider applications from would-be manufactures of the copycat biotech drugs.

The Generic Pharmaceutical Association says the FDA already has the scientific knowledge to approve knockoffs, just as it now can sign off on the changes made by brand-name biotech companies in how they produce their drugs.

'The commissioner is acknowledging that when brands make changes to their products, they are no longer identical to the approved product, but FDA follows sound science to review and approve these changes. This same sound science will be used to review biogenerics for safety and efficacy,' said Kathleen Jaeger, the generic drug industry group's president and chief executive officer.