Last week, Walgreens and Kroger filed an antitrust lawsuit against J&J and it subsidiary, Janssen, in the US District Court for the Eastern District of Pennsylvania—the same court that Pfizer also brought suit against J&J in 2017—making similar allegations to the earlier suit.
Walgreens and Kroger are seeking a permanent injunctive 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.
Remicade has been on the market since receiving FDA approval in 1998. From 1998 to 2016, J&J had what the suit calls a monopoly on the market, as it was the only product that contained the active ingredient infliximab.
This scenario lasted until Pfizer earned FDA approval to launch its competing biosimilar product, Inflectra, at a 15% discount to the wholesale acquisition cost (WAC) of the brand-name drug. According to the suit, Remicade is sold at approximately US$4,000 per infused dose and around US$26,000 for a year’s worth of treatment, making it J&J’s top-selling drug. In addition, in 2017, Merck also received FDA approval for its biosimilar version of infliximab, Renflexis. Merck sold its product at a 35% discount to the WAC cost of Remicade, which Pfizer then matched.
Despite the introduction of these 2 lower-priced biosimilar products, J&J has been able to hold its competitors to single-digit market share, says the suit, and has actually increased the price of Remicade since the entrance of the 2 biosimilars.
Walgreens alleges that J&J’s hold on the market is due to exclusionary practices enacted through contracts and bundled discounts that have suppressed competition. J&J allegedly referred to these actions as its “Biosimilar Readiness Plan,” which included implementing exclusive contracts with insurance companies. The suit states that J&J entered into agreements with insurance companies through which insurers agreed not to cover either of the biosimilar products on their respective plans, or to only do so in rare cases. Insurers that do list the biosimilar on their plans only do so in “fail-first” cases, requiring that the patient first uses the brand-name product, and if the desired outcome is not achieved, then the patient is able to use the covered biosimilar.
The suit also alleges that J&J engaged in exclusionary rebates and bundling arrangements in exchange for insurers’ agreement not to cover biosimilar infliximab drugs, according to the suit, increasing the consequence to the insurers if they choose not to enter into such agreements.
Full Content: JD Supra