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Biogeneric science

Perhaps more than for other regulated industries, science and politics are joined at the hip when it comes to the biotech and pharmaceutical sectors. This was especially evident in the background maneuvering over generic biologics during the recent Senate debate over Medicare and generic drugs.

While the Senate did not vote on pending legislation to investigate a regulatory pathway for biogenerics, the issue is certain to remain on congressional agendas as the generics industry gears up for a multiyear campaign to create an abbreviated process for biologics.

The rhetoric also is certain to pit the economic interests of consumers against the economic interests of patent holders. But to have insight into the feasibility of biogenerics, it is important to separate the politics from the science, and to focus on the science.

Fundamental differences between biologics and small molecule drugs make it impossible to apply the traditional generic model - approval based solely on preclinical data and pharmacokinetic/pharma-codynamic (PK/PD) studies in healthy volunteers - to all biologics.

But it is possible to categorize different groups of biologics by their complexity, immunogenicity and the kinds of data that would be necessary to show equivalence to the originator drug.

Therefore it also is possible to use scientific criteria to create categories of biologics that conceivably could be approved based on relatively less clinical data and those that would require much more extensive human testing prior to approval.

Based on such a framework, the FDA might find a rationale to approve a follow-on version of human growth hormone (hGH) supported by animal and PK/PD studies, while a reproduction of a monoclonal antibody might need far more clinical data.

Guidance documents on FDA's approach to generic versions of hGH and insulin were expected to be released for public comment earlier this year. They remain in bureaucratic limbo, however, as the agency has stopped talking about the topic in the midst of heavy politicking in Washington by both the innovator and generic camps. Nevertheless, the underlying science, FDA's past statements on the issue, as well as its actions on some of the critical components, suggest a broad outline for regulating biogenerics.

The framework

The Hatch-Waxman Act, which established procedures for the approval of generic drugs, does not apply to products regulated as biologics, but FDA has suggested that it interprets the law to permit generic versions of biologics that are regulated as drugs. The ANDA requirements establish a base onto which the agency could require varying amounts of additional preclinical and clinical data.

To obtain an ANDA, the sponsor of a

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