On Wednesday, Pfizer filed a lawsuit against Johnson & Johnson (J&J), claiming J&J’s anticompetitive contracts with health insurers, hospitals, and doctor groups for Remicade prevented biosimilar competition.
According to Pfizer’s press release:
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 first biosimilar for Remicade, Pfizer’s Inflectra, went on sale in November 2016 at a 15 percent discount. Inflectra was the first biosimilar monoclonal antibody (mAb) approved in the U.S. In April 2017, the FDA approved Renflexis, another Remicade biosimilar, developed by Samsung Bioepis Co. and marketed by Merck & Co.
“Pfizer said in the suit that J&J is offering discounts on its Remicade treatment in exchange for essentially excluding Pfizer’s drug from insurance coverage, keeping it out of the hands of patients,” Reuters reported in an article, adding that J&J said in an email statement “the lawsuit was without merit and that the company is competing on value and price.”
Originally, insurers classified Infectra as being equivalent to Remicade (in short: there’s no medical reason to favor one over the other), according to Pfizer. But 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,” insurers changed course:
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.
UnitedHealth Group, Anthem Inc, Aetna Inc, and Cigna Corp are among the insurers included in the contracts. The companies, Pfizer’s lawsuit claims, cover approximately 70 percent of the commercially-insured patients in the U.S.
Remicade costs an average of $4,000 per dose ($26,000/year), while Inflectra is currently 19 percent lower than the list price, Pfizer states in the suit.
According to FirstWord Pharma:
Remicade, which Johnson & Johnson markets in partnership with Merck & Co., amassed nearly $7 billion in revenue last year, including $4.8 billion in U.S. sales. Johnson & Johnson markets Remicade in the U.S., while Merck sells the drug in certain countries outside the U.S., including in Europe. In July, Merck and partner Samsung Bioepis announced the U.S. launch of their Remicade biosimilar Renflexis (infliximab-abda).
Pfizer filed a suit in the U.S. District Court for the Eastern District of Pennsylvania.
(Sources: Pfizer, Reuters, AP, FirstWord Pharma)
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Filed Under: Drug Discovery