Pfizer's Infliximab Biosimilar Approved In US But Won't Launch Against Inflectra
Executive Summary
Ixifi (infliximab-qbtx), which references Janssen's Remicade, marks first US approval of a biosimilar developed entirely by Pfizer; big pharma says it is not currently planning to launch Ixifi because it remains "committed" to marketing Celltrion's Inflectra.
Pfizer Inc.'s Ixifi, a biosimilar version of Janssen Biotech Inc.'s tumor necrosis factor inhibitor Remicade (infliximab), received FDA approval Dec. 13, but the big pharma, which already markets an infliximab biosimilar, is not planning to compete against itself for now.
Ixifi (infliximab-qbtx) is approved for all of the eligible indications on the Remicade label: adult and pediatric Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
The approval is notable for Pfizer because it marks the first US licensure of a biosimilar wholly developed by the big pharma company.
However, Pfizer currently markets another infliximab biosimilar, Celltrion Inc.'s Inflectra (infliximab-dyyb), in the US.
A Pfizer spokesman said the company is "committed to Inflectra" and although it is evaluating options with regard to Ixifi, "we are not currently planning to launch in the US."
Pfizer's decision means that the status quo remains for the US infliximab market, where two biosimilars, Inflectra and Samsung Bioepis Co. Ltd./Merck & Co. Inc.'s Renflexis (infliximab-abda), are struggling to gain ground against the still dominant Remicade.
No Change In Celltrion Partnership
Pfizer gained commercialization rights to Inflectra through its September 2015 acquisition of Hospira Inc. (Also see "Where's the value in Pfizer's $17bn Hospira buy?" - Scrip, 6 Feb, 2015.)
At the time of the deal, Pfizer's infliximab biosimilar, known as PF-06438179, was in Phase III trials, and the European Commission required Pfizer to divest the product as part of its antitrust review. (Also see "EU Demands Pfizer Offload Infliximab Biosimilar In Hospira Buy " - Scrip, 5 Aug, 2015.)
Although Sandoz Inc. acquired rights to the product in Europe, Pfizer retained commercialization and manufacturing rights to its infliximab biosimilar in all countries outside of the 28 nations that form the European Economic Area. (Also see "Sandoz Picks Up Pfizer's Infliximab Biosimilar " - Scrip, 12 Feb, 2016.)
In the US, the Federal Trade Commission did not find that the overlap between Hospira's and Pfizer's infliximab biosimilars would be anticompetitive and did not require divestment of either product. (Also see "Pfizer/Hospira's Biosimilar Pipeline: Substantial Overlap, Limited Divestiture So Far" - Scrip, 4 Sep, 2015.)
FDA approved Inflectra in April 2016 and Pfizer launched the biosimilar seven months later at a 15% discount to Remicade. (Also see "Pfizer Will Support Inflectra Launch With Dedicated Sales Force" - Scrip, 14 Nov, 2016.)
While Pfizer is sticking with Inflectra for now, the Ixifi approval gives it some options in the event there is a change in its partnership with Celltrion.
In addition, Pfizer does not have commercial agreements with the South Korean-based company in all markets and could opt to launch Ixifi in countries where it does not sell Inflectra.
The Pfizer spokesman said the Ixifi approval does not change anything with regard to the company's partnership with Celltrion, the terms of which are confidential.
Five US Biosimilar Approvals In 2017
Ixifi becomes the ninth biosimilar licensed in the US and the fifth approved in calendar year 2017.
At least five other 351(k) applications are currently under review with user fee goal dates in the first half of 2018. (See the Pink Sheet Performance Tracker for a listing of biosimilar submissions and approvals.)
The Pfizer biosimilar was approved within the 10-month timeframe for applications submitted under the first iteration of the Biosimilar User Fee Act (BsUFA). That timeframe increased to 12 months under BsUFA II, starting with applications submitted on or after Oct. 1.
However, the increased pace of biosimilar submissions and approvals in the past few years has not translated into a bolus of new products reaching the US market due to ongoing patent disputes between reference product sponsors and biosimilar sponsors.
To date, only three products have launched: Inflectra, Renflexis and Sandoz Inc.'s Zarxio (filgrastim-sndz), a biosimilar of Amgen Inc.'s Neupogen (filgrastim) and the first 351(k) application to receive FDA approval.
Difficult Commercial Environment Spawns Litigation
Even for those that have launched, the commercial dynamics have proven challenging.
In September, Pfizer sued Janssen and parent company Johnson & Johnson alleging that the Remicade sponsor's exclusionary contracts and other anticompetitive practices have effectively blocked Inflectra from accessing 70% of the commercial market. (Also see "Pfizer Sets The Stage For A Biosimilar Showdown Over Exclusive Contracts" - Scrip, 20 Sep, 2017.)
In November, J&J filed a motion to dismiss the lawsuit, asserting the complaint fails to adequately plead antitrust injury or harm to competition.
In a corrected memorandum of law supporting the dismissal motion, Janssen said Pfizer's lawsuit "seeks to dictate and circumscribe the nature of the price incentives Janssen can offer in order to reduce the degree to which Pfizer would have to price compete and cut into its own profits."
Pfizer's lawsuit "seeks to dictate and circumscribe the nature of the price incentives Janssen can offer in order to reduce the degree to which Pfizer would have to price compete and cut into its own profits." – Janssen
"Pfizer has not pled facts (as opposed to conclusory allegations) showing that Janssen’s discounts and rebates, rather than Pfizer’s own unwillingness to offer lower prices on Inflectra or bundled discounts on Pfizer’s many profitable, billion-dollar products, are the cause of Inflectra’s alleged poor record to date," the memorandum states. "Without such facts, Pfizer cannot plausibly plead that the cause of its alleged harm has been Janssen’s competitive strategy."
Janssen asserts the complaint is silent on whether Pfizer has sought to compete against Janssen by offering bundled discounts on its own wide range of drug products, and whether it has actually offered a lower Inflectra net price to payers than the Remicade net price offered by Janssen after all discounts and rebates are taken into account.
Pfizer has until Jan. 12 to respond to the dismissal motion.