By Baltazar Gomez --
We previously reported on the passage by the U.S. Senate Committee on Health, Education, Labor & pensions of bill S.1695, entitled "The Biologics Price Competition and Innovation Act of 2007." The bill's sponsors stated that the bill reflects a balanced approach that enables patients to have safe and effective biological drugs, while giving incentives to generic companies to bring low-cost versions to market. The bill seeks to provide regulatory routes necessary to establish an approval process for generic biologics comprising the creation of a scientifically rigorous, efficient, and FDA-driven pathway, as well as a mechanism for timely resolution of patent disputes.
An article in the Chicago Tribune by staff reporter Bruce Japsen, however, paints a less glowing picture (see "Path May Clear for Biotech Generics"). Although cheaper biogenerics would be good news for consumers and for companies producing the biogenerics, innovator companies would see painful revenue reduction. As the article points out, many innovator companies are already facing revenue reduction from expiring patents, and if the House approves a similar bill, innovator companies could face additional revenue reduction. Presently, there is no regulatory pathway within the FDA to bring biogenerics to market.
As beneficial as the bill seems for biogeneric companies, the generic industry cites critical issues that undercut the cost benefit to consumers. For instance, Teva, a generic maker and significant patent holder, has stated that it would prefer a shorter exclusivity period closer to that provided by the Hatch Waxman Act than the unprecedented twelve years of market exclusivity the bill would provide to an innovator company. And according to Kathleen Jaeger, president of the Generic Pharmaceutical Association, the bill would also allow innovator companies to make a minor change to a biologic drug and receive an additional twelve years of exclusivity (see "Victory of Sorts as 'Biogenerics' Bill Passed in US Senate"). Jaeger further argues that such practice would essentially prevent low-cost biogenerics from ever reaching patients.
At the same time, any biogeneric legislation must ensure that innovator companies have sufficient incentive and patent protection to create and develop new biologics in addition to provide safe biogenerics. Congress faced similar problems in the chemical drugs industry during the passage of the Hatch-Waxman Act in 1984. But the Hatch-Waxman Act does not apply to biologics, which inherently differ from chemical drugs. For example, biologics are made in living systems, such as micro-organisms, plants, or animal cells. Biologics are usually produced by recombinant DNA technology and comprise very large and complex molecules. Thus, biologics are extremely difficult to replicate and will require a separate set of regulatory rules.
For additional information on this and other related topics, please see:
- "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
- "Three New Biosimilars Pass EMEA Test," July 26, 2007
- "European Medicines Agency Releases Paper on Biosmiliar Medicines," July 23, 2007
- "Senate Committee Passes Biologics Legislation," July 5, 2007
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