Antitrust regulators to increase scrutiny of biosimilar deals
US competition regulators will increase scrutiny of biologic and biosimilar-related patent settlements, as they look to crack down on antitrust violations.
The US Federal Trade Commission (FTC) made the commitment in a joint statement issued with the US Food and Drug Administration (FDA) yesterday, February 3.
The statement pledges a joint effort from the two agencies to crack down on anti-competitive behaviour in the biologics and biosimilar industries.
In particular, they will look to crack down on tactics which prevent generic developers from accessing reference samples, which are required for testing in order to obtain biosimilar status.
The FTC also committed to reviewing patent settlement agreements involving biosimilars for signs of anti-competitive behaviour, under the 2018 Patient Right to Know Drug Prices Act.
“Such review will occur in the same manner that FTC has been reviewing patent settlement agreements between brand and generic drug manufacturers,” the statement said.
So-called ‘pay-for-delay’ deals have come under increased scrutiny, leading California to become the first US state to impose a formal ban last year.
These are agreements which see patent owners pay to keep generic drugs off the market, and often come in the form of settlements to patent litigation.
California passed a law outlawing pay-for-delay deals last October, while generic manufacturers are currently challenging the statute at the US Court of Appeals for the Ninth Circuit.
Stephen Hahn, FDA commissioner said that: “Strengthening efforts to curtail and discourage anti-competitive behavior is key for facilitating robust competition for patients in the biologics marketplace, including through biosimilars, bringing down the costs of these crucial products for patients.”
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