Senators Urge FTC to Investigate AbbVie Humira Settlements

Earlier this month, US Senators Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minnesota, sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the FTC to “examine whether makers of biologic medicines are using strategies like ‘pay-for-delay’ to hinder or delay biosimilars from entering the market.”

According to the letter, “Biologics play an important role in treating many serious illnesses and are among the fastest growing classes of therapeutic products… Without biosimilar competition, US patients and payers will likely see additional price increases on biologics in the years to come.”

The senators cite examples of alleged pay-for-delay strategies, specifically the settlement agreements that pharmaceutical company AbbVie has entered into with both Amgen and Samsung Bioepis over their adalimumab biosimilars, referenced on AbbVie’s originator product, Humira. The drug is the world’s top-selling prescription product, with annual sales of $16 billion.

Under each of the settlement agreements, Amgen and Samsung are unable to launch their biosimilars in the United States until 2023, but both products will be available for purchase on the European market as soon as the end of 2018.

“This means that while European patients will benefit from biosimilar competition later this year, Americans may be without access to Humira biosimilars for almost 5 more years. While such terms in patent settlement agreements may not always be inappropriate, the incentives for parties to delay biosimilar entry are present, and biologic markets could be susceptible to patent settlement abuse,” reads the letter.

Furthermore, this is not the first time that the FTC has been called on to investigate these very settlements. In April 2018, patient advocacy group Patients for Affordable Drugs (P4AD) also urged the FTC to examine the same agreement between AbbVie and Samsung.

“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 the president and co-founder of P4AD, David Mitchell, in a statement.

Conversely, AbbVie has strongly opposed using the term “pay-for-delay” to describe the agreements. In a prior 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].”