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Scrip Regulatory Affairs
US House and Senate panels favour 12-year data exclusivity for pioneer biologics
05 August 2009
Vibha Sharma

A US congressional committee has voted in favour of providing innovative biologic drug manufacturers with 12 years of data exclusivity for their products as part of ongoing efforts to establish a regulatory framework for the approval of biosimilars. It has also supported blocking pay-for-delay deals between brand-name and generic pharmaceutical companies...

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