Johnson and Johnson (J&J) recently filed a motion to dismiss in the antitrust claim brought against the company by Walgreen and Kroger in regard to sales of J&J’s reference infliximab product, Remicade. In early December, the District Court for the Eastern District of Pennsylvania denied the motion.
Johnson and Johnson (J&J) recently filed a motion to dismiss in the antitrust claim brought against the company by Walgreen and Kroger in regard to sales of J&J’s reference infliximab product, Remicade. In early December, the District Court for the Eastern District of Pennsylvania denied the motion.
In June 2018, Walgreen and Kroger filed an antitrust suit against J&J and its Janssen division seeking permanent injunctive relief and damages “arising out of [J&J and Janssen’s] unlawful exclusion of biosimilar competition to the brand name drug Remicade,” according to the suit.
The suit is similar to another antitrust suit filed by Pfizer against J&J in November 2017 in the same court. According to the suit, when Pfizer earned FDA approval for its infliximab biosimilar, Inflectra, it sold the product at a 15% discount to the wholesale acquisition cost (WAC) of the brand name drug. In addition, Merck also received FDA approval for its own biosimilar infliximab, Renflexis, in the same year which was sold at a 35% discount to the WAC cost of Remicade.
Despite the introduction of 2 lower-priced products, J&J maintained its hold on the market and limited its competitors to single-digit market share and has been able to increase the price of Remicade since the introduction of the biosimilars.
Walgreen alleged that J&J’s hold on the market is due to exclusionary practices enacted through “contracts and bundled discounts that have suppressed competition.” Furthermore, the suit states that J&J entered into agreements with insurers through which they agreed not to cover either of the biosimilar products on their respective plans, or to only do so in rare cases.
According to the order of dismissal, J&J moved to dismiss Walgreens and Kroger’s claim on 2 grounds: J&J alleged that the retailers’ claims did not sufficiently allege antitrust violations, and that because the retailers do not have consent from the distributors to pursue these claims, they lacked antitrust standing.
On the first ground, the court found that, similar to the case brought by Pfizer, the complaint “plainly and repeatedly emphasizes that, as a result of the anticompetitive behavior,” the plaintiffs have “paid inflated prices for those products.”
Finally, in regard to the second ground, the Court converted J&J’s motion into one for summary judgement, and will hear additional evidence and briefing. “Motions must be submitted within 45 days and any factual development shall be limited to whether the assignment to Retailer Plaintiffs was valid,” read the order.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.