Pfizer sues Johnson & Johnson alleging its anticompetitive practices have denied U.S. patients access to biosimilar competitors including Inflectra (infliximab-dyyb).

Pfizer has filed suit in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson (J&J). The suit alleges that J&J�s exclusionary contracts and other anticompetitive practices have denied U.S. patients access to therapeutic options and undermined the benefits of robust price competition in the innovative and growing biologics marketplace for patients. It further claims that J&J�s systematic efforts to maintain its monopoly in connection with Remicade (infliximab) by inappropriately excluding biosimilar competitors violates federal antitrust laws and undermines the principal goals of the federal Biologics Price Competition and Innovation Act (BPCIA).

The complaint describes how insurers originally classified Inflectra at parity with Remicade � meaning, there was no medical reason to favor Remicade over Inflectra. However, insurers reversed course after J&J threatened to withhold significant rebates unless insurers agreed to �biosimilar-exclusion� contracts that effectively block coverage for Inflectra and other infliximab biosimilars. In the absence of such coverage, providers � who depend on reimbursement from insurers � are reluctant to stock biosimilars, even to service Medicare and Medicaid patients where there is widespread coverage for Inflectra. Additionally, J&J offered providers anticompetitive contracts conditioned on the providers not purchasing biosimilars to Remicade in exchange for discounts on Remicade. These anticompetitive practices are preventing physicians from trying and patients from accessing the biosimilar.

J&Js exclusionary contracts have also caused insurers not to cover Pfizer�s Inflectra even though the Pfizer biosimilar is available at a Wholesale Acquisition Cost (WAC) that is 19 percent lower than that of Remicade, and has an Average Selling Price (ASP) that is more than 10 percent lower � with Pfizer offering additional pricing concessions to compete vigorously against the dominance of Remicade. Moreover, the recent Q3 ASP published by the Centers for Medicare and Medicaid Services (CMS) continues the trend of increases in Remicade's ASP despite the launch of Inflectra, which has seen a decline in its ASP each quarter.

Comment:This litigation could be a critical case for biosimilars in the US as J&J defensive activities such as,- steep discounts, denial of rebates not only on Remicade but other J&J products and exclusive contracts that exclude coverage to Inflectra,- mean that Pfizer has found it difficult to secure reimbursement for Inflectra from commercial payers. Inflectra has so far secured less than 4% of total infliximab sales in the US.