Noticia de Contratación

Yesterday, Congressman John Sarbanes, D-Maryland, introduced the Biosimilars Competition Act of 2018 in the United States House of Representatives. The bill would require biologic and biosimilar drug manufacturers to report any agreements they enter into that may keep lower-cost drugs from reaching consumers.

“This bill will help lower prescription drug costs by bringing more affordable biosimilar drugs to the market,” said Congressman Sarbanes in an email to The Center for Biosimilars®. “Some biologic drug manufacturers make deals with biosimilar manufacturers to keep biosimilars off the market, retain their market share, and keep prices high.”
 
A number of these agreements have made the news and come under more scrutiny recently. Specifically, pharmaceutical manufacturer AbbVie recently struck its third agreement with a biosimilar developer over Humira. AbbVie currently has similar deals in place with Mylan, Samsung Bioepis, and Amgen, each one staving off biosimilar competition for Humira in the United States until 2023.

AbbVie faced criticism over such settlements as earlier this month, when Senators Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minnesota, urged the Federal Trade Commission (FTC) to investigate whether these settlements are “pay-for-delay” tactics designed to keep patients from accessing cheaper medications.

Delays of biosimilar market entry have also garnered more attention lately, as the FDA Commissioner Scott Gottlieb, MD, announced with the release of the Biosimilar Action Plan initiatives that the FDA will be implementing to further spur competition, as well as a partnership between the FDA and the FTC to address anticompetitive behaviors.

“[Biosimilar] competition is, for the most part, anemic…we’re not going to play regulatory whack-a-mole with companies trying to unfairly delay or derail the entry of biosimilar competitors,” said Gottlieb.

Notably, the bill introduced by Sarbanes will not allow the FTC to retrospectively investigate such agreements. Instead, “The bill we introduced [yesterday] will require biologic manufacturers and biosimilars manufacturers to submit all deals to the FTC and the Department of Justice for review so that they can monitor these agreements and take action against bad actors,” he said.

Congressman Sarbanes noted that he’s hopeful that “this bipartisan bill—one that will help lower prescription drug prices and save millions of dollars for hardworking Americans—will be considered by the full [House of Representatives] or included as part of another legislative package that comes to the floor.”