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.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Cost and Efficacy Insights on Infliximab Biosimilars in Pediatric Uveitis
December 3rd 2024The study highlights the safety, efficacy, and cost benefits of infliximab biosimilars in managing pediatric noninfectious uveitis, showing fewer disease flares and reduced costs compared with reference infliximab, as well as the influence of insurance mandates on treatment decisions.
Perceptions of Biosimilar Switching Among Veterans With IBD
December 2nd 2024Veterans with inflammatory bowel disease (IBD) prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.