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Generic, biosimilar patent settlements save $423B

The settlements have brought more affordable medicines to market more than 5 years earlier.
Levy

The Association for Accessible Medicines and its Biosimilars Council have released an analysis undertaken by the IQVIA Institute for Human Data Science on behalf of AAM assessing the impact of patent settlements in expediting patient access to lower-cost medicine. 

The analysis shows that patent settlements between brand and generic/biosimilar medicine manufacturers accelerated patient access to generic and biosimilar medicines to market by, on average, more than five years before patent expiration. Savings to the healthcare system from patent settlements since the FTC v. Actavis decision in 2013 total $423 billion, and the average savings to the healthcare system per molecule are $5 billion.

“The ability for generic and biosimilar manufacturers to procompetitively settle with brand-name drug manufacturers creates significant savings and efficiencies and brings lower-cost medicines to patients years earlier,” said John Murphy III, president and CEO of AAM. 

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]

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Murphy III added, “Efforts to severely limit patent settlements will hurt patients, cost billions of dollars, and exacerbate industry sustainability concerns in the generic medicines marketplace.”

The IQVIA Institute assessed 288 molecules for settlement information. Of those, 84 had settlements that accelerated generic or biosimilar entry by, on average, 64 months prior to patent expiration. Of those 84 settlements, 17% accelerated generic or biosimilar entry by more than a decade prior to patent expiry. 

[Read more: Biosimilar Council comments on IQVIA report on biosimilar void]

The 84 molecules combined were brought to market a total of 5,365 months earlier, totaling savings for the healthcare system of $423 billion. The average savings to the healthcare system per molecule was approximately $5 billion.

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