Biotech industry struggles with generics approval

San Francisco

Leaders of the biotechnology industry hit out this week at the slowness of regulators in getting to grips with a problem that is confronting the industry as it comes of age: how to get approval for generic versions of biotech drugs after patents expire.

At the annual meeting of the Biotechnology Industry Organization (BIO) in San Francisco this week, industry managers and lawyers expressed frustration at not knowing what they have to do to get generics approved. “We don't know what the rules are,” complains Meredith Manning, a regulatory lawyer at Washington, DC-based law firm Hogan & Hartson, who represents biotech firms. This will considerably lengthen the time for cheaper generics to reach the market, she says.

Drug patents are now expiring 17 years after they were first filed. In the United States, generics need approval from the Food and Drug Administration (FDA). This is straightforward for most drugs, which have a single active ingredient — usually a small molecule — whose purity and composition can be confirmed by chemical testing.

But the drugs that the biotechnology industry has developed tend to be large molecules such as antibodies and other proteins, whose identities cannot be confirmed by a simple chemical analysis. Manufacturers of generic versions of these products will need to show equivalence with the original in another way. And the FDA has not yet said how this should be done.

Biotech generics are on sale now, but they have had to submit to costly new drug reviews, including clinical trials. Among the generics approved by this route are recombinant human insulin and the anti-cancer drug interferon-alpha. But dozens more biotech patents will expire in the next few years.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research at Rockville, Maryland, says that the agency is working hard to have guidelines available for public review, perhaps later this year. “We fully intend to have a transparent process,” she says.


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Knight, J. Biotech industry struggles with generics approval. Nature 429, 588 (2004).

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