Patient Group Calls on FTC to Investigate Humira Settlement, AbbVie Cries Foul

In a letter last week, patient advocacy group Patients for Affordable Drugs (P4AD) called on the Federal Trade Commission (FTC) to examine whether a pay-for-delay deal allegedly struck between reference adalimumab (Humira) manufacturer AbbVie with biosimilar developer Samsung Bioepis violates anti-competitive and antitrust laws.

The deal is the second agreement AbbVie has made for the blockbuster anti—tumor necrosis factor therapy since 2017. The first agreement was made with drug manufacturer Amgen, staving off the US market entry of its adalimumab biosimilar until 2023. This most recent deal with Samsung Bioepis, which involves the same date for US market entry as the Amgen deal, gives the pharmaceutical company 5 more years without biosimilar competition. Samsung Bioepis' proposed biosimilar, SB5, has not yet been approved by the FDA.

“AbbVie is using pay-for-delay deals to keep a cheaper generic off the market and patients are the victims. We believe it is illegal and anti-competitive, and we are asking the FTC to step in and protect patients from AbbVie’s price hikes,” said David Mitchell, president and co-founder of P4AD, in a statement.

P4AD’s letter was sent to the acting chairwoman of the FTC and to lawmakers, including leaders of the Senate and House Appropriations Committees. Signed by Mitchell, the letter addressed the cost of Humira and the harm it its high pricing has caused to the patients who depend on the drug.

“Humira is incredibly expensive and costs patients and taxpayers billions. Over the past 5 years, the price has more than doubled. Its most recent price increase of 9.7% in January of this year will cost the US healthcare system $1.2 billion. We have patients all over the country who are hurt by these pay-for-delay deals,” the letter reads.

Conversely, AbbVie has strongly objected to use the term “pay-for-delay” to describe the adalimumab agreements. In a statement, the company said “AbbVie’s settlements with Amgen and Samsung Bioepis are in no way pay-for-delay arrangements. AbbVie is not paying Amgen or Samsung Bioepis, and in fact both Amgen and Samsung Bioepis will be paying royalties to AbbVie once their adalimumab biosimilar products launch in the [United States].”

In addition to the letter, P4AD also encouraged patients to write to their senators in support of changes that would put an end to such settlements, and says that, to date, more than 1200 patients have written to show their support.