Baltimore, Maryland, Sues Both AbbVie and Amgen Over Humira

April 2, 2019
Kelly Davio

Yet another class action lawsuit has been filed against AbbVie, maker of the brand-name adalimumab, Humira. The latest suit, brought by the mayor and city council of Baltimore, Maryland, on behalf of themselves and others similarly situated, alleges that, absent AbbVie’s conduct, biosimilar adalimumab could have been available in the United States as early as 2016. It also alleges that biosimilar developer Amgen was paid by AbbVie to delay its marketing of a biosimilar adalimumab.

Yet another class action lawsuit has been filed against AbbVie, maker of the brand-name adalimumab, Humira. The latest suit, brought by the mayor and city council of Baltimore, Maryland, on behalf of themselves and others similarly situated, alleges that, absent AbbVie’s conduct, biosimilar adalimumab could have been available in the United States as early as 2016. It also alleges that biosimilar developer Amgen was paid by AbbVie to delay its marketing of a biosimilar adalimumab.

The complaint, filed on March 22, 2019, in the Northern District of Illinois, claims that AbbVie established a thicket of patents, some with clear deficiencies, to ward off biosimilar competition and allow the brand-name Humira to “command supra-competitive prices.”

The complaint also states that AbbVie paid Amgen by awarding the biosimilar developer de facto market exclusivity by giving the company the first market entry date—January 2023—for its biosimilar, while AbbVie negotiated later marketing dates for other biosimilar products. “Amgen, thus, will have [5] months as the only biosimilar on the market, enabling it to charge higher prices and realize hundreds of millions of dollars in higher profits than it would if it faced competition during this period,” reads the complaint.

According to the suit, while Amgen was not entitled to any period of market exclusivity as a first biosimilar under the Biologics Price Competition and Innovation Act (unlike the Hatch-Waxman Act’s 180-day exclusivity period for first generics), the settlement that Amgen entered into with AbbVie “gave Amgen precisely that. AbbVie agreed not to settle with any other manufacturers on terms that would let them enter the market at the same time as Amgen, or for [5] months thereafter.”

Baltimore claims that the overcharges to Humira that result from the alleged conduct of the 2 drug makers are traceable through the pharmaceutical distribution chain to the city and to other end payers, and asks that the court award damages of 3 times the amount of the overcharges. The complaint also asks for injunctive relief “to stop AbbVie’s unlawful conduct.”

In a statement, Baltimore’s City Solicitor, Andre M. Davis, JD, said, “When big pharma violates the law and engages in schemes to overcharge Baltimore, we will pursue legal recourse to recover millions of taxpayer dollars. Our resources are needed for essential services for our people and to keep taxes down. Tax payer dollars should not go to unjustly enrich large corporations.”

The lawsuit is the latest in a spate of complaints against AbbVie; in September 2018, the State of California filed suit alleging that the company provided kickbacks to healthcare providers throughout the state to encourage them to prescribe its brand-name Humira and that it used a network of registered nurses to mislead patients about the risks associated with the drug. Then, last month, labor union United Food and Commercial Workers Local 1500 filed a class action lawsuit against AbbVie over its alleged patent thicket and alleged collusion with biosimilar developers to divide the market for adalimumab between Europe and the United States.