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WHO guidelines presage US biosimilars legislation?

Nature Biotechnology volume 27, pages 963–964 (2009)Cite this article

When the US Congress enacted the US Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act 25 years ago, opening the way for the FDA to approve generic drugs, biologics were not included. Bill Haddad, chairman and CEO of Biogenerics in Brewster, New York, who was instrumental in initiating and negotiating the Hatch-Waxman Act takes that omission personally. “I made a big mistake 25 years ago,” he says, “and it's time to make amends.” He is working with generics industry lobby groups such as the Generic Pharmaceutical Association in Arlington, Virginia, to accelerate the passage of US legislation on biosimilars. “The stakes are high,” says Haddad. “There are 25–30 [biologic] drugs out there with what amounts to perpetual patents.” History demonstrates, he believes, just how profound an impact biosimilars legislation could have. “Thirty-five years ago, when we were first thinking about the legislation that became Hatch-Waxman, generic compounds had only 5% [by volume] of the US pharmaceuticals market: now they have 85%.”

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    John Hodgson

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Hodgson, J. WHO guidelines presage US biosimilars legislation?. Nat Biotechnol 27, 963–964 (2009). https://doi.org/10.1038/nbt1109-963a

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