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Data vs. market 'exclusivity' in blockbuster scrap over biosimilars

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Lobbyists for two powerful groups--healthcare payers and drug developers--are marshalling their forces for a legislative dust-up over the meaning of the word "exclusivity" in the new biosimilar law. And the formal definition that they ultimately settle on will be worth billions to the winning side.

On one side you'll find insurers like Aetna, according to a report from the Wall Street Journal. Payers maintain that the bill allows for four years of data exclusivity and 12 years of market exclusivity, giving biosimilar developers a shot at getting a competing therapy on the market right at the end of the 12-year cap. And on the other side are developers like Amgen, which have the most to lose if the insurers get their way. They are saying that the bill allows for 12 years of data exclusivity, which would prevent biosimilar developers from accessing data on existing biologics until the end of the protected period. That would significantly delay the entry of competing products, keeping the competition at bay.

"We are extremely concerned about possible interpretations...that could further delay the availability of generic biologic drugs, restricting access for many Americans and driving up costs for the federal government," assert four senators, including John McCain. Biotech companies counter that lawmakers intended to provide developers with the more generous interpretation of the law in order to encourage innovation.

Who's right? Neither side, generic drug lawyer Kurt Karst of Hyman Phelps & McNamara PC tells the WSJ. The law doesn't specifiy, leaving Congress with yet another biosimilar scrap to settle.

- here's the article from the Wall Street Journal

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