NIVESTYM™, a biosimilar to Neupogen®
(filgrastim), is Pfizer’s fourth biosimilar to be approved by the FDA
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.)
Food and Drug Administration (FDA) has approved NIVESTYM™
(filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim),
for all eligible indications of the reference product.
“The FDA approval of NIVESTYM marks an important step in helping expand
access to critical treatment options for patients with neutropenia, many
of whom have cancer and can be hospitalized for potentially
life-threatening side effects stemming from chemotherapy,” said Berk
Gurdogan, U.S. Institutions President, Pfizer Essential Health. “We
believe biosimilars, like NIVESTYM, are essential in helping to address
evolving healthcare needs and may provide more affordable medicines to
The FDA approval was based on a review of a comprehensive data package
and totality of evidence demonstrating a high degree of similarity of
NIVESTYM compared to its reference product.
In the U.S., NIVESTYM is indicated:2
To decrease the incidence of infection, as manifested by febrile
neutropenia, in patients with nonmyeloid malignancies receiving
myelosuppressive anti-cancer drugs associated with a significant
incidence of severe neutropenia with fever.
For reducing the time to neutrophil recovery and the duration of
fever, following induction or consolidation chemotherapy treatment of
patients with acute myeloid leukemia (AML).
To reduce the duration of neutropenia and neutropenia-related clinical
sequelae, e.g., febrile neutropenia, in patients with nonmyeloid
malignancies undergoing myeloablative chemotherapy followed by bone
marrow transplantation (BMT).
For the mobilization of autologous hematopoietic progenitor cells into
the peripheral blood for collection by leukapheresis.
For chronic administration to reduce the incidence and duration of
sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal
ulcers) in symptomatic patients with congenital neutropenia, cyclic
neutropenia, or idiopathic neutropenia.
NIVESTYM is expected to be available in the U.S. at a significant
discount to the current wholesale acquisition cost (WAC) of Neupogen.
WAC is not inclusive of discounts to payers, providers, distributors and
other purchasing organizations.
NIVESTYM is Pfizer’s fourth biosimilar to be approved by the U.S. FDA.
Pfizer’s biosimilars pipeline consists of 10 distinct biosimilar
molecules with five assets in mid-to-late stage clinical development.3
NIVESTYM™ IMPORTANT SAFETY INFORMATION
Do not take NIVESTYM if you have had a serious
allergic reaction to human G-CSFs such as filgrastim or pegfilgrastim
Before you take NIVESTYM, tell your healthcare provider all about
your medical conditions, including if you:
have a sickle cell disorder
have kidney problems
are receiving radiation therapy
are pregnant or plan to become pregnant. It is not known if NIVESTYMwill harm your unborn baby
are breastfeeding or plan to breastfeed. It is not known if NIVESTYMpasses into your breast milk
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and
How will I receive NIVESTYM?
NIVESTYMinjections can be given by a healthcare provider
by intravenous (IV) infusion or under your skin (subcutaneous
injection). Your healthcare provider may decide that subcutaneous
injections can be given at home by you or your caregiver. If NIVESTYMis given at home, see the detailed “Instructions for Use” that
comes with your NIVESTYMprescription for information on
how to prepare and inject a dose of NIVESTYM.
You and your caregiver should be shown how to prepare and inject
NIVESTYM, before you use it, by your healthcare provider.
Your healthcare provider will tell you how much NIVESTYMto
inject and when to inject it. Do not change your dose or stop NIVESTYMunless your healthcare provider tells you to.
If you are receiving NIVESTYMbecause you are also
receiving chemotherapy, your dose of NIVESTYMshould be
injected at least 24 hours before or 24 hours after your dose of
If you miss a dose of NIVESTYM, talk to your healthcare provider about
when you should give your next dose.
What are the most common side effects of NIVESTYM?
The most common side effects of NIVESTYM include aching in the bones
What are possible side effects of NIVESTYM?
NIVESTYM may cause serious side effects including:
Spleen rupture. Your spleen may become enlarged and can
rupture. A ruptured spleen can cause death.
Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious
Serious allergic reactions. These can occur anywhere in your
body. If you have an allergic reaction, stop using NIVESTYM.
Sickle cell crises. Serious sickle cell crises have happened in
people with sickle cell disorders receiving NIVESTYM that have
sometimes led to death.
Kidney injury (glomerulonephritis). NIVESTYM can cause kidney
Capillary Leak Syndrome. NIVESTYM can cause fluid to leak from
blood vessels into your body’s tissues. This condition is called
“Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have
symptoms that may become life-threatening.
Decreased platelet count (thrombocytopenia). Your healthcare
provider will check your blood during treatment with NIVESTYM. Tell
your healthcare provider if you have unusual bleeding or bruising
during treatment with NIVESTYM. This could be a sign of decreased
platelet counts, which may reduce the ability of your blood to clot.
Increased white blood cell count (leukocytosis). Your
healthcare provider will check your blood during treatment with
Inflammation of your blood vessels (cutaneous vasculitis). Tell
your healthcare provider if you develop purple spots or redness of
Call your healthcare provider or seek emergency medical help right
away if you have:
pain in the left upper stomach area or left shoulder
symptoms of sickle cell crisis such as pain or trouble breathing
shortness of breath, with or without a fever, any trouble breathing,
wheezing or a fast rate of breathing
a rash over your whole body, swelling around your mouth or eyes, fast
heart rate and sweating
swelling or puffiness, especially swelling of your stomach-area and
feeling of fullness
swelling of your face and ankles
blood in your urine or dark colored urine
less than usual urination
dizziness or are feeling faint
a general feeling of tiredness
These are not all the possible side effects of NIVESTYM. Call your
healthcare provider for medical advice about side effects.
You are encouraged to report adverse events related to Pfizer products
by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact
the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch
or call 1-800-FDA-1088.
Please see full Prescribing
Information and Patient Information for NIVESTYM (filgrastim-aafi).
Working together for a healthier world®
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to people that extend and significantly improve their lives. We strive
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DISCLOSURE NOTICE: The information contained in this release is as of
July 20, 2018. 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 NIVESTYM™
(filgrastim-aafi), including its 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 launch timing and commercial success of NIVESTYM in the
United States; the uncertainties inherent in research and development;
whether and when any applications for NIVESTYM may be filed with
regulatory authorities in any other jurisdictions; whether and when
regulatory authorities in any other jurisdictions may approve any such
other applications that are pending or that may be filed for NIVESTYM,
which will depend on the assessment by such regulatory authorities of
the benefit-risk profile suggested by the totality of the efficacy and
safety information submitted and, if approved, whether NIVESTYM will be
commercially successful; intellectual property and/or litigation
implications; decisions by regulatory authorities regarding labeling and
other matters that could affect the availability or commercial potential
of NIVESTYM; uncertainties regarding access challenges for our
biosimilar products where our product may not receive access at parity
to the innovator product and remains in a disadvantaged position; and
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, 2017, 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
1 Neupogen® is a registered trademark of Amgen Inc.
Nivestym™ (filgrastim-aafi) Prescribing Information. New York. NY:
Pfizer Inc: 2018. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761080s000lbl.pdf?utm_campaign=FDA%20approves%20Nivestym%20%28filgrastim-aafi%29%20a%20biosimilar%20to%20Neupogen%20%28filgrastim%29&utm_medium=email&utm_source=Eloqua.
Pfizer. (2018, January 30). Pfizer pipeline. Retrieved from https://www.pfizer.com/sites/default/files/product-pipeline/01302018_PipelineUpdate.pdf.
Thomas Biegi, +1 212-733-2204
Crowe, +1 212-733-8160