Tony Hagen is senior managing editor for The Center for Biosimilars®.
The US Public Interest Research Group (PIRG) contends AbbVie's patent thicket for Humira (adalimumab) will encourage anticompetitive practices by other manufacturers.
The US Public Interest Research Group (PIRG) has filed an amicus brief in support of a 7th Circuit Court of Appeals case against AbbVie alleging anticompetitive practices over the company’s blockbuster product Humira (adalimumab).
Plaintiffs in UFCW Local 1500 Welfare Fund v AbbVie Inc allege AbbVie’s numerous patent filings have effectively blocked biosimilars from entering the market, allowing the company to charge more for adalimumab than if the competitive marketplace were untrammeled by this “patent thicket.”
The PIRG brief states that a 1-year supply of Humira in the United States, where there is no biosimilar competition for Humira currently, increased 144% from 2012 to 2018. Costs of a year-long supply have been as much as $48,612, the brief states. Meanwhile, biosimilar competition for adalimumab in Europe has led to discounts as deep as 80%.
“Neither inflation nor higher manufacturing costs explain these price increases. As the record demonstrates, most of Humira’s US patents were set to expire in 2016, but AbbVie engaged in a patent thicket strategy that allowed the company to prolong its Humira monopoly for years beyond what Congress intended,” PIRG states.
Numerous companies have reached agreements with AbbVie to launch their adalimumab biosimilars in 2023 on a staggered schedule.
Failed Class Action Suit
In June 2020, the US District Court for the Northern District of Illinois, Eastern Division, dismissed a class action suit against AbbVie with a finding of insufficient merit to the claims of misconduct and antitrust violations alleged by the plaintiffs.
An element of PIRG’s argument is the alleged influence AbbVie’s product protection tactics may have on other originator companies looking to extend exclusivity for their drugs, too. The group contends this will lead to excessive patent fillings by other manufacturers. “Make no mistake, the district court’s decision with respect to AbbVie’s conduct will have huge ramifications going forward,” PIRG said.
“Pay for delay” is a label that has been attached to the multiple agreements AbbVie has reached with biosimilar developers to postpone their adalimumab marketing until 2023. Until now, the Federal Trade Commission (FTC), which has authority to enforce antitrust laws, has not brought a public enforcement action involving biosimilars. But the allegations lodged in the contention between originator and biosimilar drug developers have attracted its notice.
The AbbVie class action suit ruled on in June is among 2 prominent cases that the FTC has been watching closely, according to Markus H. Meier, acting director for the FTC’s Bureau of Competition. The other case is Pfizer v Johnson & Johnson (J&J). Pfizer has alleged that J&J unfairly employed rebate payments to discourage use of the company’s infliximab biosimilar (Inflectra). The biosimilar has been available for use in the US since 2016 but has achieved just a 10.5% share of the market.
“What’s interesting is that Pfizer is one of the largest drug companies in the world and yet it’s having problems, so maybe there’s really something going on here,” Meier said at the American Conference Institute’s 11th Summit on Biosimilars & Innovator Biologics.