Pfizer Sues J&J Over Anti-Competitive Practices With Remicade Biosimilars
Pfizer has filed suit in the US District Court for the Eastern District of Pennsylvania against Johnson & Johnson (J&J) on the grounds of anti-competitive practices, particularly in reference to J&J’s top-selling inflammatory drug Remicade (infliximab), which had 2016 sales of $6.97 billion.
In its suit, Pfizer alleges that “J&J’s exclusionary contracts and other anti-competitive practices have denied US patients access to therapeutic options and undermined the benefits of robust price competition in the innovative and growing biologics marketplace for patients. It [the suit] further claims that J&J has used systematic efforts to maintain its monopoly in connection with Remicade by inappropriately excluding biosimilar competitors, which Pfizer said violates federal antitrust laws and undermines the principal goals of the federal Biologics Price Competition and Innovation Act (BPCIA).” The BPCIA, part of the Patient Protection and Affordable Care Act, created an approval pathway in the US for biosimilar and interchangeable biological products.
After the BPCIA became law in 2010, Pfizer launched its biosimilar to J&J’s Remicade, Inflectra (infliximab-dyyb), in late 2016. Pfizer’s complaint describes how insurers originally classified Inflectra at parity with Remicade. However, the company said 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. Additionally, Pfizer said J&J offered providers anti-competitive contracts conditioned on the providers not purchasing biosimilars to Remicade in exchange for discounts on Remicade.
In addition to Inflectra, another biosimilar to Remicade, Renflexis (infliximab-abda), was launched in July 2017 from Merck & Co. and Samsung Bioepis, a joint venture between Samsung BioLogics, a contract biologics manufacturer, and Biogen.