U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™
On July 23rd, 2018
U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™
(filgrastim-aafi)
Release Date:
Friday, July 20, 2018 4:24 pm EDT
Terms:
Dateline City:
NEW YORK
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
Administ ration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen
1 (filgrastim), for all eligible
indications of the reference product.
“The FDA approval of NIVESTYM marks an important step in helping expand access to critical t reatment options for patients
with neut ropenia, 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
patients.”
The FDA approval was based on a review of a comprehensive data package and totality of evidence demonst rating 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 neut ropenia, in patients with nonmyeloid malignancies
receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neut ropenia with fever.
For reducing the time to neut rophil recovery and the duration of fever, following induction or consolidation
chemotherapy t reatment of patients with acute myeloid leukemia (AML).
To reduce the duration of neut ropenia and neut ropenia-related clinical sequelae, e.g., febrile neut ropenia, in patients
with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow t ransplantation (BMT).
For the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by
leukapheresis.
For chronic administ ration to reduce the incidence and duration of sequelae of severe neut ropenia (e.g., fever,
infections, oropharyngeal ulcers) in symptomatic patients with congenital neut ropenia, cyclic neut ropenia, or idiopathic
neut ropenia.
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, dist ributors 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
products.
Before you take NIVESTYM, tell your healthcare provider all about your medical conditions, including if you:
How will I receive NIVESTYM?
NIVESTYM injections can be given by a healthcare provider by int ravenous (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 “Inst ructions 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 chemotherapy.
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 injury.
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 lifethreatening.
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during
t reatment with NIVESTYM. Tell your healthcare provider if you have unusual bleeding or bruising during t reatment 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
t reatment with NIVESTYM.
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 t rouble breathing
shortness of breath, with or without a fever, any t rouble 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 Administ ration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA1088.
Please see full Prescribing Information 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 st rive 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 work across developed and emerging markets to advance wellness,
prevention, t reatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as
Ticker: PFE
Exchange: NYSE
ISIN:
US7170811035
one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments
and local communities to support and expand access to reliable, affordable health care around the world. For more than 150
years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to
investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
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 www.sec.gov and www.pfizer.com .
1 Neupogen® is a registered t rademark of Amgen Inc.
2 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%28filgrastimaafi%29%20a%20biosimilar%20to%20Neupogen%20%28filgrastim%29&utm_medium=email&utm_source=Eloqua.
3 Pfizer. (2018, January 30). Pfizer pipeline. Ret rieved from https://www.pfizer.com/sites/default/files/productpipeline/01302018_PipelineUpdate.pdf.
Language:
English
Contact:
Pfizer Inc.
Media:
Thomas Biegi, +1 212-733-2204
Thomas.Biegi@pfizer.com
or
Investors:
Ryan Crowe, +1 212-733-8160
Ryan.Crowe@pfizer.com
Ticker Slug:
Source URL: http://press.pfizer.com/press-release/us-fda-approves-pfizers-biosimilar-nivestym-filgrastim-a
U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™
(filgrastim-aafi)
Release Date:
Friday, July 20, 2018 4:24 pm EDT
Terms:
Dateline City:
NEW YORK
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
Administ ration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen
1 (filgrastim), for all eligible
indications of the reference product.
“The FDA approval of NIVESTYM marks an important step in helping expand access to critical t reatment options for patients
with neut ropenia, 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
patients.”
The FDA approval was based on a review of a comprehensive data package and totality of evidence demonst rating 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 neut ropenia, in patients with nonmyeloid malignancies
receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neut ropenia with fever.
For reducing the time to neut rophil recovery and the duration of fever, following induction or consolidation
chemotherapy t reatment of patients with acute myeloid leukemia (AML).
To reduce the duration of neut ropenia and neut ropenia-related clinical sequelae, e.g., febrile neut ropenia, in patients
with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow t ransplantation (BMT).
For the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by
leukapheresis.
For chronic administ ration to reduce the incidence and duration of sequelae of severe neut ropenia (e.g., fever,
infections, oropharyngeal ulcers) in symptomatic patients with congenital neut ropenia, cyclic neut ropenia, or idiopathic
neut ropenia.
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, dist ributors 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
products.
Before you take NIVESTYM, tell your healthcare provider all about your medical conditions, including if you:
How will I receive NIVESTYM?
NIVESTYM injections can be given by a healthcare provider by int ravenous (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 “Inst ructions 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 chemotherapy.
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 injury.
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 lifethreatening.
Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during
t reatment with NIVESTYM. Tell your healthcare provider if you have unusual bleeding or bruising during t reatment 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
t reatment with NIVESTYM.
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 t rouble breathing
shortness of breath, with or without a fever, any t rouble 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 Administ ration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA1088.
Please see full Prescribing Information 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 st rive 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 work across developed and emerging markets to advance wellness,
prevention, t reatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as
Ticker: PFE
Exchange: NYSE
ISIN:
US7170811035
one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments
and local communities to support and expand access to reliable, affordable health care around the world. For more than 150
years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to
investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
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 www.sec.gov and www.pfizer.com .
1 Neupogen® is a registered t rademark of Amgen Inc.
2 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%28filgrastimaafi%29%20a%20biosimilar%20to%20Neupogen%20%28filgrastim%29&utm_medium=email&utm_source=Eloqua.
3 Pfizer. (2018, January 30). Pfizer pipeline. Ret rieved from https://www.pfizer.com/sites/default/files/productpipeline/01302018_PipelineUpdate.pdf.
Language:
English
Contact:
Pfizer Inc.
Media:
Thomas Biegi, +1 212-733-2204
Thomas.Biegi@pfizer.com
or
Investors:
Ryan Crowe, +1 212-733-8160
Ryan.Crowe@pfizer.com
Ticker Slug:
Source URL: http://press.pfizer.com/press-release/us-fda-approves-pfizers-biosimilar-nivestym-filgrastim-a
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