Pfizer files lawsuit against J&J’s exclusionary contracts for Remicade


Pfizer has filed a lawsuit against Johnson & Johnson (J&J) in the US District Court for the Eastern District of Pennsylvania to ensure patients and providers have access to major, lower-cost biosimilar therapies.

As claimed by Pfizer, J&J’s exclusionary contracts and other anticompetitive practices have denied access to therapeutic options to the US patients and undermined the benefits of price competition in the new and growing marketplace for biologics.

The biosimilar exclusionary contracts have been designed by J&J to prevent insurers from covering Pfizer’s treatment even though the biosimilar is available at a 19% lower wholesale acquisition cost (WAC) and more than 10% lower average selling price (ASP) than Remicade.

This prevents patients from having access to effective lower-cost biosimilar medicines.

Also, the suit alleges that J&J has made systematic efforts to maintain its monopoly in connection with Remicade (infliximab) by inappropriately excluding biosimilar competitors.

According to the lawsuit, this practise is against the Federal Antitrust laws and undermines the primary goals of the Federal Biologics Price Competition and Innovation Act (BPCIA).

"By supporting the availability of biosimilar therapies, we can help ensure that patients have better access to a wide range of lower cost therapeutic options."

Pfizer Essential Health group president John Young said: “By offering highly similar therapeutic options for patients, doctors and health plans, biosimilars foster therapeutic choice and increased access to biologic medicines around the world.

“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 – now and in the future – based on lawful pricing and access practices.

“By supporting the availability of biosimilar therapies, we can help ensure that patients have better access to a wide range of lower cost therapeutic options.”

Last year, Pfizer launched Inflectra (infliximab-dyyb), a biosimilar to J&J’s Remicade, as the first biosimilar monoclonal antibody (mAb) in the US.

However, insurers favoured Remicade over Inflectra after J&J threatened to refuse considerable rebates unless they agreed to ‘biosimilar-exclusion’ contracts that block coverage for Inflectra and other infliximab biosimilars.

J&J is also claimed to have offered anticompetitive contracts to providers where they can receive discounts on Remicade on condition that they would not purchase other biosimilars.