- Pfizer Inc. is taking rival Johnson & Johnson to court, filing a lawsuit in the U.S. District Court for the Eastern District of Pennsylvania that alleges the multi-national conglomerate has been conducting anticompetitive practices to prevent biosimilar competition.
- The big pharma released a statement Wednesday morning claiming J&J "denied U.S. patients access to therapeutic options and undermined the benefits of robust price competition in the innovative and growing biologics marketplace."
- Pfizer goes on to charge that J&J’s contracting practices for its rheumatoid arthritis treatment Remicade deliberately boxes out biosimilar competitors, violating antitrust laws and undermining "the principal goals of the federal Biologics Price Competition and Innovation Act (BPCIA)."
Editor's Note: This article was updated with comments from J&J.
J&J has reportedly signed contracts with insurers which require patients to fail on Remicade first before using alternatives, in order for payers to receive after-market rebates.
Pfizer secured U.S. approval of its Remicade (infliximab) biosimilar Inflectra (infliximab-dyyb) in April of 2016 —only the second biosimilar to ever be approved in the U.S.
Yet, Pfizer and its partner Celltrion did not launch Inflectra until November 2016 due to pushback from J&J, which has fiercely defended the Remicade franchise.
The Inflectra launch was considered "at-risk" at the time and Pfizer priced the drug at only a 15% discount to Remicade’s wholesale acquisition cost (WAC). Pfizer said in its Wednesday statement that Inflectra is now available at a 19% discount to the Remicade WAC and has an average selling price (ASP) that is more than 10% lower, "with Pfizer offering additional pricing concessions to compete vigorously against the dominance of Remicade," the company said.
"We are effectively competing on value and price and to date, Pfizer has failed to demonstrate sufficient value to patients, providers, payers and employers," said Scott White, president of Janssen Biotech, J&J's pharmaceutical arm, in an emailed statement to BioPharma Dive. "Competition is bringing down the overall cost of infliximab including Remicade, and will continue to bring down costs in the future. There is no merit to this lawsuit."
Inflectra had sales of only $23 million in the U.S. during the second quarter of this year, while Remicade brought in $1.1 billion in the U.S. during the quarter.
Biosimilars are not exactly the same thing as small molecule generics, but generics are known for being priced at a 75% to 85% discount to their reference products. So far, biosimilar developers in the U.S. have not been offering their products at that same steep discount.
That may be due in part to the relative newness of the biosimilar market in the U.S. While biosimilars have been sold for more than a decade in Europe, a legal pathway for approval of the biologic copycats in the U.S. was only instituted in 2010. Of the six biosimilars that have now been approved by the Food and Drug Administration, only three have launched because of the ongoing legal battles being waged by the developers of the reference drugs.
"A biosimilar – by definition – has no clinically meaningful differences from the original product in terms of safety, purity, and potency. J&J’s biosimilar exclusionary contracts are designed solely to prevent Inflectra from being able to compete on its primary point of differentiation – price. This behavior prevents patients from gaining access to important lower cost biosimilar therapies," wrote Pfizer in the Sept. 20 statement.
Since the launch of Inflectra, a second Remicade biosimilar has since been approved — Samsung Bioepis and Merck & Co.’s Renflexis, which was launched at a then 35% discount to Remicade's list price.