Market Overview

U.S. FDA Approves Pfizer's Biosimilar NIVESTYM™ (filgrastim-aafi)


NIVESTYM™, a biosimilar to Neupogen®
(filgrastim), is Pfizer's fourth biosimilar to be approved by the FDA

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


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 NIVESTYM
    will harm your unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if NIVESTYM
    passes into your breast milk

Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and
herbal supplements.

How will I receive NIVESTYM?

  • NIVESTYM injections 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 NIVESTYM
    is given at home, see the detailed "Instructions for Use" that
    comes with your NIVESTYM prescription 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 NIVESTYM to
    inject and when to inject it. Do not change your dose or stop NIVESTYM
    unless your healthcare provider tells you to.
  • If you are receiving NIVESTYM because you are also
    receiving chemotherapy, your dose of NIVESTYM should 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
    and muscles.

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
    lung problem.
  • 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
    your skin.

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
or call 1-800-FDA-1088.

Please see full Prescribing
and Patient Information for NIVESTYM (filgrastim-aafi).

Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best-known consumer health care products. Every day, Pfizer colleagues
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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
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, 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

1 Neupogen® is a registered trademark of Amgen Inc.
Nivestym™ (filgrastim-aafi) Prescribing Information. New York. NY:
Pfizer Inc: 2018. Available at
Pfizer. (2018, January 30). Pfizer pipeline. Retrieved from

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