Pfizer Goes to Court to Allow Competition for Biologics and Expand Options for Patients
September 20 2017 - 9:10AM
Business Wire
Lawsuit Claims Johnson & Johnson Engaged
in Unlawful Conduct to Stifle Competition From Inflectra
To ensure patients and providers have access to important, lower
cost biosimilar medicines, Pfizer (NYSE:PFE) today filed suit in
the U.S. District Court for the Eastern District of Pennsylvania
against Johnson & Johnson (J&J).
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).
“By offering highly similar therapeutic options for patients,
doctors and health plans, biosimilars foster therapeutic choice and
increased access to biologic medicines around the world,” said John
Young, Pfizer’s group president, Essential Health. “For U.S.
patients and providers to realize the benefits of biosimilars, new
and existing biosimilar entrants should have a fair chance to
compete with originator products – now and in the future – based on
lawful pricing and access practices. By supporting the availability
of biosimilar therapies, we can help ensure that patients have
better access to a wide range of lower cost therapeutic
options.”
The U.S. biosimilars marketplace is at a relatively early stage
of development compared to other countries such as those in Europe.
Since Congress passed the BPCIA, which became law in 2010, three
biosimilars approved by the U.S. Food and Drug Administration (FDA)
have been launched. A biosimilar to J&J’s Remicade, Inflectra®
(infliximab-dyyb) was launched by Pfizer in the U.S. in late 2016
as the first biosimilar monoclonal antibody (mAb).
The complaint describes how insurers originally classified
Inflectra at parity with Remicade – meaning, there was no medical
reason to favor Remicade over Inflectra. However, insurers reversed
course 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. 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.
J&J’s exclusionary contracts have also caused insurers not
to cover Pfizer’s Inflectra even though the Pfizer biosimilar is
available at a Wholesale Acquisition Cost (WAC) that is 19 percent
lower than that of Remicade, and has an Average Selling Price (ASP)
that is more than 10 percent lower – with Pfizer offering
additional pricing concessions to compete vigorously against the
dominance of Remicade. Moreover, the recent Q3 ASP published by the
Centers for Medicare and Medicaid Services (CMS) continues the
trend of increases in Remicade's ASP despite the launch of
Inflectra, which has seen a decline in its ASP each quarter.
“Congress enacted the BPCIA to improve patient access to more
affordable treatment options and to foster meaningful price
competition for biologic products,” said Douglas Lankler, executive
vice president, general counsel, Pfizer Inc. “J&J’s behavior
runs counter to the spirit of this law and to U.S. antitrust laws.
We are filing this suit to help ensure that patients can benefit
from, and have access to, lower cost biosimilar therapies.”
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.
“As evident by their success in markets such as Europe, we know
biosimilars can improve patient access to important, life-saving
medicines. We stand with patients and are fully committed to
deliver on the increased therapeutic choices and potential savings
that biosimilars can bring; however, we must make sure there are no
artificial barriers in the commercial insurance market that may
limit coverage and use of biosimilars,” Young said. “It’s not in
the best interest of patients and our healthcare system if
originator companies like J&J can use their dominant market
position to prevent access to lower cost, effective biosimilar
medicines in the U.S. Pfizer is committed to challenging practices
like those implemented by J&J that block biosimilar options for
patients and price competition – through the courts and by working
with policymakers and regulators – so that patients have a wide
range of treatment options available to them at a competitive
price.”
DISCLOSURE NOTICE: The information contained in this release is
as of September 20, 2017. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information about
INFLECTRA® (infliximab-dyyb) and a suit filed by Pfizer in the U.S.
District Court for the Eastern District of Pennsylvania against
J&J, including their potential benefits, that involves
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
uncertainties regarding the outcome and impact of the suit filed
against J&J uncertainties regarding the commercial success of
INFLECTRA; the uncertainties inherent in research and development;
intellectual property and/or litigation implications; relationship
with the application sponsor; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of INFLECTRA; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended
December 31, 2016, including in the sections thereof captioned
"Risk Factors" and "Forward-Looking Information and Factors That
May Affect Future Results", as well as in its subsequent reports on
Form 10-Q and Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available
at www.sec.gov and www.pfizer.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20170920005755/en/
PfizerMedia:Thomas Biegi,
212-733-2204Thomas.Biegi@pfizer.comorInvestors:Ryan Crowe,
212-733-8160Ryan.Crowe@pfizer.com
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