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Second US biosimilars bill introduced: 12 instead of five years market exclusivity Posted 06/07/2009

On 17 March 2009, US Congresswoman Anna Eshoo (Democrat of California, USA) introduced a second biosimilars bill in the House that will compete with the bill introduced a week ago by US Congressman Henry Waxman, Chairman of the House Energy and Commerce Committee. Both bills would create the first US approval pathway for follow-on biologics. The bills differ in areas such as length of exclusivity for innovators and the need for guidance documents.

Biotech lobbyists loudly cheered the newly-introduced bill that offers 12 years of market exclusivity to branded biologicals before they have to confront a generic competitor. “The bill provides patients with the right balance between innovation and competition," said US Biotechnology Industry Organization (BIO) President Jim Greenwood.

Mr Greenwood and the rest of the biotech industry, though, face tough legislative competition from the bill offered by Mr Henry Waxman that provides only five years of exclusivity for biologicals. After years of arguing over issues like the safety of biosimilars and the kind of discounts that they could offer the marketplace, lawmakers are now down to only one: How much time should a biological be given before a biosimilar is allowed to compete with it?

For biotech companies, the difference between five years and 12 years of exclusivity could amount to billions of dollars. Mega-blockbusters earn more than US$2 billion (Euros 1.43 billion) a year. But there is a lot of support in US Congress to pass those savings on to consumers as soon as possible. And the debate appears headed for a final resolution sometime this year.

Source: Fierce Biotech, 18 March 2009; FDA news, Drug Daily Bulletin, 19 March 2009

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