Motion to dismiss Inflectra case denied, but J&J insists ‘Pfizer’s lawsuit is without merit’
In September 2017, Pfizer accused Johnson & Johnson (J&J) of restricting uptake of Inflectra – a biosimilar to J&J’s bestselling monoclonal antibody (mAb) Remicade (infliximab) – via biosimilar-exclusion contracts. Pfizer also claimed J&J offered discounts on Remicade to providers, dependent on them not purchasing infliximab alternatives.
Inflectra (infliximab) is indicated for the treatment of a number of diseases, including Rheumatoid Arthritis, Crohn’s Disease, and Plaque Psoriasis.
J&J had recommended the court dismiss Pfizer’s claims, however, last week, district court judge James Curtis Joiner announced the motion had been denied.
“J&J’s efforts to foreclose Pfizer from the market, as Pfizer has alleged, have led to increased prices for consumers and limited competitive options for end payers, providers, and patients,” said Joiner in a memorandum.
“Pfizer provides detailed allegations regarding J&J’s exclusionary terms with many of the nation’s largest insurers, the incentive structure that forces end payers and providers into accepting those terms, Pfizer’s efforts to compete, including its guarantees that Inflectra would cost less than Remicade, and showed how market participants on many levels are injured from J&J’s ability to sell Remicade without having to compete with Inflectra and other biosimilars,” Joiner added.
Pfizer is “pleased” with the court’s decision “and that this case can now move forward,” a Pfizer spokesperson told us.
The company “believes that this anti-competitive conduct cannot continue if we want to have a vibrant biosimilar market in the United States,” we were told.
J&J: ‘Pfizer’s lawsuit is without merit’
Janssen – J&J’s biopharmaceutical subsidiary – told us it stands by its Remicade pricing decisions: “Janssen maintains our position that Pfizer’s lawsuit is without merit.”
“We stand by our contracts and will continue competing on value and price to help ensure patients have affordable access to Remicade. In contracting for Remicade, payers and providers have demanded, and we have provided, aggressive discounts. Since we are competing vigorously, healthcare system costs will go down.
“We deliver a variety of innovative contracting options, discounts and rebates to payers, providers and pharmacy benefit managers, to ensure Remicade remains an affordable option for patients and physicians,” the spokesperson added.
FDA in action?
The decision made by the US District Court for the Eastern District of Pennsylvania comes one month after the US Food and Drug Administration (FDA) published its Biosimilar Action Plan. One of plan’s primary aims is to encourage biosimilar competition.
Competition in the biosimilar industry is largely “anaemic”, said FDA Commissioner Scott Gottlieb at the time.
“It’s anaemic, because consolidation across the supply chain has made it more attractive for manufacturers, Pharmacy Benefit Managers, Group Purchasing Organisations and distributors to split monopoly profits through lucrative volume-based rebates on reference biologics – or on bundles of biologics and other products – rather than embrace biosimilar competition and lower prices,” he added.
In July 2018, a Pfizer spokesperson told us the firm was encouraged by the FDA’s support of biosimilars, but said “more work needs to be done to tear down market barriers to biosimilars and it will require cooperation from a robust coalition of stakeholders, from congress and insurers to the FDA, to biologics manufacturers, and the middle-men.”