Pfizer takes on J&J with antitrust lawsuit
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 U.S. biosimilars marketplace is at a relatively early stage of development compared to other countries such as those in Europe. Since Congress passed the BPCIA, which became law in 2010, three biosimilars approved by the U.S. Food and Drug Administration (FDA) have been launched. A biosimilar to J&J’s Remicade, Inflectra® (infliximab-dyyb) was launched by Pfizer in the U.S. in late 2016 as the first biosimilar monoclonal antibody (mAb).
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&J’s 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. ■