Pfizer files US lawsuit against Johnson & Johnson over "anticompetitive" practices related to Remicade biosimilar

Pfizer on Wednesday announced the filing of a lawsuit in US district court alleging that Johnson & Johnson's "exclusionary contracts and other anticompetitive practices" have denied patients access to biosimilar versions of Remicade (infliximab). The suit also claims that Johnson & Johnson's "systematic efforts to maintain its monopoly…by inappropriately excluding biosimilar competitors violates federal antitrust laws." 

John Young, Pfizer's group president for Essential Health, remarked that "for US patients and providers to realise the benefits of biosimilars, new and existing biosimilar entrants should have a fair chance to compete with originator products…based on lawful pricing and access practices." Pfizer launched its Remicade biosimilar Inflectra (infliximab-dyyb) in the US late last year.

According to Pfizer's complaint, US insurers had originally classified Inflectra at parity with Remicade, but later reversed course when Johnson & Johnson "threatened to withhold significant rebates unless insurers agreed to 'biosimilar-exclusion' contracts that effectively block coverage for Inflectra and other infliximab biosimilars." Pfizer also claims that Johnson & Johnson offered "anticompetitive contracts conditioned on the providers not purchasing biosimilars to Remicade in exchange for discounts" on the drug. 

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Pfizer argues that Johnson & Johnson's actions have led insurers not to cover Inflectra even though its wholesale acquisition cost is 19 percent lower than Remicade, and its average selling price is more than 10 percent lower. Pfizer also noted that according to a recent report by the US Centers for Medicare and Medicaid Services, the average selling price for Remicade continues to grow despite the availability of Inflectra. 

Pfizer general counsel Douglas Lankler stated "Congress enacted the [Biologics Price Competition and Innovation Act] to improve patient access to more affordable treatment options and to foster meaningful price competition for biologic products," adding that "Johnson & Johnson's behaviour runs counter to the spirit of this law and to US antitrust laws." 

Remicade, which Johnson & Johnson markets in partnership with Merck & Co., amassed nearly $7 billion in revenue last year, including $4.8 billion in US sales. Johnson & Johnson markets Remicade in the US, while Merck sells the drug in certain countries outside the US, including in Europe. In July, Merck and partner Samsung Bioepis announced the US launch of their Remicade biosimilar Renflexis (infliximab-abda).

For additional analysis, see ViewPoints: As lawsuit against Johnson & Johnson is filed, FirstWord's new biosimilar report sheds light on Pfizer's Inflectra challenges in US market.

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