FDA Indicates Biotech Knockoffs Might Have Different Status Than "Generics"

Pharmacy benefits managers would not be able to simply subsitute generic biopharmaceuticals for the brand-name products without consent.

Continuing my ongoing coverage on this topic (including my original post, a follow-up based on NYT coverage, recent news that legislators have finally introduced a bill that would enable the FDA to approve generic biopharmaceuticals, and my post on the Express Scripts study that suggested that generic insulin could save $797+ million in the first year, and in excess of $16 billion over 10 years), today's Associated Press featured an article that I think should address anyone's remaining concerns about opening the door to generic biopharmaceuticals (or as the FDA prefers to call them, "follow-on" protein products) such as insulin. Its important to note that the pending legislation would enable the FDA to require additional clinical trial results if the agency feels they are necessary to approve a generic biopharmaceutical.

But by classifying follow-on protein products as something other than generics, the FDA is indicating that generic biopharmaceuticals would not exactly be considered generics, which are identical, or bioequivalent to the brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use and are therefore interchangable with the brand name. Instead, follow-on protein medicines would be considered similar enough to be used in place of a brand-name, but not quite interchangable. The bottom line is that pharmacists would not be able to subsitute a cheaper generic version without telling you. This is basically the situation with insulin today. Sure, Humalog, Novolog and Apidra are rapid-acting analogs, but a patient cannot necessarily switch from one brand to another without making adjustments. I think the Associated Press calling them a "lower" status than a generic is a misnomer, rather it would be a different status than a generic, meaning it can be used to treat the same condition, just not interchangably with the brand-name version -- adjustments might need to be made. This would provide patients with access to lower-cost insulin, but would not force them to switch simply because their healthcare provider wants you to take the cheaper version.

For more complete details on this subject, please see the article that follows, as well as the links above.

FDA: Biotech Knockoffs Earn Lower Status
By Andrew Bridges, Associated Press
March 15, 2007

WASHINGTON -- 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.

This article originally appeared at:
http://www.washingtonpost.com/wp-dyn/content/article/2007/03/15/AR2007031501650.html