Senators Ask FTC to Analyze How Pay-For-Delay Deals Affect Biosimilar Access

The Federal Trade Commission should examine the impact of “pay-for-delay” deals on the availability of cheaper biosimilars, according to Sens. Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.).

The senators expressed concerns in a letter to the FTC about pay-for-delay settlements, noting that they are estimated to cost up to $3.5 billion a year in higher drug costs. For example, AbbVie has entered several global settlement agreements over the past year with companies such as Amgen and Samsung under which the companies agreed not to launch their biosimilars for AbbVie’s Humira until 2023 in the U.S. market.

While these arrangements are not always inappropriate, they could potentially create perverse incentives to delay biosimilar entry, Klobuchar and Grassley wrote.

“AbbVie’s patent settlements with Amgen and Samsung Bioepis are absolutely not a ‘pay for delay,’” an AbbVie spokesperson told FDAnews. “AbbVie did not make any payments to Samsung Bioepis or Amgen under the announced agreements, and Amgen and Samsung Bioepis will each pay royalties to AbbVie for licensing our Humira patents once their adalimumab biosimilar products are launched. This is a straightforward patent license.”