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GEN Poll

Mar 20, 2009

Legislation on Biosimilars

With all political eyes on making healthcare more affordable, the issue of how to bring biosimilars to market has everyone riled up. The need for cheaper drug options is pitted against the importance of protecting innovation.

Brand-name firms ask for significant clinical trial data before approval to ensure the new versions are true copies with the closest possible safety profile and efficacy. They’d also like at least 14 years of market exclusivity to ensure the ability to generate profits after a long and costly development process. Companies focusing on biosimilars would prefer to avoid going through every clinical trial phase, stating that proving safety and efficacy can be done in a quicker manner. And of course, they want to get their biosimilars on the market asap. Politicians are currently reviewing a proposal that would confer at least five years of market exclusivity. So where do you stand?

Should approval of biosimilars be based on brand-name firms—who want longer exclusivity and significant clinical development requirements, or biosimilar companies—who want the opposite?

Innovator companies’ suggestions
Biosimilar makers’ ideas
Somewhere in between

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