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Waxman: US biosimilars market opens this year Posted 06/07/2009

“Seeing a pathway for biological generics is one of my highest priorities this year,” US Congressman Henry Waxman said via a video link to the World Generics Medicines Congress Europe 2009, held in London, UK, in February.

According to Mr Waxman, US legislation to open the door for biosimilars (called follow-on proteins or biogenerics in the US) will be completed by the end of the year. He said the US is in need of a scientific regulatory pathway to open up competition, prevent the monopoly of high priced biologicals and offer affordable life-saving medicines to the US population.

 

Mr Waxman said he knew the FDA already had the expertise to begin approving biosimilars. “The FDA wants to use its authority to determine the approvals,” he stressed. “A balanced bill is expected to be passed before the end of the year.”

 

According to Mr Waxman, US Congress is confident in the efficacy and safety of biosimilars. He said he was eager to strike a balance for both the generics/biosimilars markets as well as to encourage innovation among the key biological companies.

 

Mr Waxman pointed out the US legislation will have five key components. First, the FDA should make science-based decisions as to whether a drug can be safely used, looking at clinical evidence. Second, the bill should allow for improvements in scientific technology and not discourage scientific innovation. Third, it should not impose unnecessary procedural hurdles, such as guidance requirements. Fourth, the bill should include early resolutions of patent disputes. And fifth, the legislation should have adequate incentives for innovation, without unnecessary delays for competition.

 

Mr Waxman is an influential Californian Congressman, who together with Senator Orrin Hatch of Utah designed the Hatch-Waxman Act, which was intended to promote drug price competition via generics – with 180 days exclusivity to first-to-file generics – while leaving intact a financial incentive for R&D. Mr Waxman concluded this Act was now being abused.

Source: APM Health

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