Companies Could Face Generic Competition On Biotechnology Drugs

Armen Hareyan's picture

Generic Competition On Biotechnology Drugs

The San Francisco Chronicle on Sunday examined how biotechnology companies soon could face generic competition under a bipartisan Senate bill (S 1695)proposed by Democrats Edward Kennedy (Mass.) and Hillary Rodham Clinton(N.Y.) and Republicans Orrin Hatch (Utah) and Mike Enzi (Wyo.). Underthe legislation, biotech companies would get 12 years of marketexclusivity after FDA approval, compared with five years for traditional brand-name medicines.


The Generic Pharmaceutical Associationsaid a 12-year period of market exclusivity is "arbitrary andexcessive." Association CEO Kathleen Jaeger said, "It's just going tounjustifiably delay access to consumers."

However, "some advocates of generics acknowledge that biological medicines are harder to develop than traditional drugs," the Chroniclereports. The Senate bill includes a provision that would requiregeneric biologic makers to perform clinical trials to prove drugefficacy, a step not required of traditional generic drugmanufacturers. FDA would be allowed to waive that requirement under thelegislation.

Members of a congressional conference committeeover the next few weeks will "try to cobble together" a bill that "boththe Senate and House can accept," the Chronicle reports (Tansey, San Francisco Chronicle, 7/15).

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