FTC Seeking Information About J&J's Strategy for Brand-Name Infliximab, Remicade

The Federal Trade Commission (FTC) issued civil subpoenas to Johnson & Johnson (J&J) in June as part of an antitrust investigation into the contracting practices for the autoimmune drug Remicade, the originator infliximab sold by its Janssen unit, the company said in a regulatory filing on Monday.

In the 10-Q filing with the Securities and Exchange Commission, J&J said that the FTC had issued a civil investigative demand (CID). The equivalent of a subpoena, a CID is one tool the FTC can use to determine whether the contracting practices were legal.

In 2017, Pfizer sued J&J, alleging that J&J’s contracts with payers for Remicade were anticompetitive and aimed to block sales of Pfizer’s infliximab biosimilar, Inflectra, which was approved in 2016.

Pfizer argues in the lawsuit that J&J’s insurer contracts provide discounts in exchange for providing a preference to Remicade. In addition, Pfizer says the contracts only pay for Inflectra if Remicade is proven to be ineffective. J&J is fighting the Pfizer lawsuit, but in August 2018, the district court for the Eastern District of Pennsylvania denied J&J’s motion to dismiss the case.

In a statement sent to The Center for Biosimilars^®, Pfizer said it also received a CID in June.

“We believe the Federal Trade Commission’s (FTC’s) decision to open an investigation into the competitiveness in the biosimilars market is an important step, which we hope will lead to a robust, competitive marketplace for patients and physicians to access biosimilar medicines,” said Pfizer’s representative. “As Pfizer’s complaint alleges, J&J’s unlawful conduct is designed to prevent Inflectra from being able to compete on its primary point of differentiation—price. Today, Inflectra has an Average Selling Price that is more than 22% lower than Remicade. Despite these facts, J&J has not lost substantial volume or share of sales—counter to what should occur in a competitive market.”

Remicade, an infusion, is approved for use for rheumatoid arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis. It about $4000 per dose, or $26,000 per year.

In the 10-Q filing, J&J said it “operates in an environment increasingly hostile to intellectual property rights.”