FTC investigates J&J contracts regarding the drugmaker's blockbuster Remicade
In September 2017, Pfizer filed a lawsuit alleging that J&J was colluding with insurers to ensure the company’s blockbuster autoimmune disease drug, Remicade, was given first preference over its cheaper biosimilar. On Monday, J&J disclosed that the US Federal Trade Commission (FTC) was investigating whether the company had violated antitrust laws, in a regulatory filing.
J&J’s Remicade, first approved in 1998, is a biologic used to treat various ailments including rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis. In the second quarter, the Band-Aid maker generated $1.12 billion in global Remicade sales.
Pfizer’s Inflectra is a biosimilar version of Remicade and was granted US approval in 2016.
Unlike generics — which can be readily substituted for branded medicines — biosimilars are not exact copies of expensive biologics, which are made from living cells, and are therefore not interchangeable (unless they are categorized as such by the FDA). In the United States, biosimilars have seen modest uptake, in part due to the smaller magnitude of difference in list price between the branded biologic and biosimilar.
In its lawsuit in 2017, Pfizer said that J&J threatened to withhold significant rebates unless insurers agreed to contracts that effectively thwarted coverage for Inflectra and other Remicade biosimilars.
These exclusionary contracts have pushed insurers to not cover “Inflectra even though the Pfizer biosimilar is available at a Wholesale Acquisition Cost that is 19 percent lower than that of Remicade, and has an Average Selling Price (ASP) that is more than 10 percent lower,” Pfizer said in a statement.
J&J on Monday said the FTC had issued a “civil investigative demand” — which is on par with a subpoena — to determine if its contracting practices were legal.
Endpoints News has contacted Pfizer for comment.
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