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​​​​​​NYVEPRIA(pegfilgrastim-apgf) is an FDA-approved biosimilar to Neulasta® (pegfilgrastim)​​​​​​1*†

NYVEPRIA offers the potential to help address treatment costs and was approved by the FDA based on the totality of evidence supporting high similarity to Neulasta1-3

32% of commercially insured patients have access to NYVEPRIA nationwide, as of April 2022​​​​​​​2§‖

Download the National Coverage Brochure

Approved for the eligible indication of Neulasta1  

See full indication

Identical dosing and administration schedule to Neulasta1

Review dosing information

NYVEPRIA PD/PK data supports no clinically meaningful differences in efficacy vs Neulasta-US2

Studies in support of biosimilarity in healthy volunteers
​​​​​​​

PD=pharmacodynamic; PK=pharmacokinetic.

Review clinical data

NYVEPRIA had a comparable safety profile vs Neulasta across adverse event categories​​​​​​​2

Studies in support of biosimilarity in healthy volunteers

Review safety data

Pfizer Oncology Together™ Co-Pay Savings Program for Injectables

Eligible, commercially insured patients# may pay as little as $0 per NYVEPRIA treatment.** See full Terms and Conditions below.

  • This program covers up to $10,000 per calendar year††
  • There are no income requirements for patients to qualify
  • Patients enrolled in state- or federally funded prescription insurance programs are not eligible for this program
  • For information on enrollment, claims submissions, and reimbursement, visit PfizerOncologyTogether.com to download the Co-Pay Savings Program Brochure
FOR LIVE, PERSONALIZED SUPPORT
Call 1-877-744-5675 (Monday-Friday, 8 AM-8 PM ET)
Learn more about the program

   *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar and the reference product.1

    †NYVEPRIA does not have a designation of interchangeability with Neulasta.

    ‡WAC is a manufacturer’s undiscounted or list price to wholesalers/direct purchasers and, therefore, is not inclusive of discounts to payers, providers, distributors, and other purchasing organizations. Data as of May 2022.

    §Percentage of commercial lives where NYVEPRIA is covered at parity or at an advantage to Neulasta.

     ‖Medical policy data are current as of April 2022. Please verify individual patient benefits to confirm coverage.


    ¶Terms and Conditions: By using this program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions below:

  • The Pfizer Oncology Together Co-Pay Savings Program for Injectables for NYVEPRIA™ is not valid for patients who are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
  • Program offer is not valid for cash-paying patients.
  • With this program, eligible patients may pay as little as $0 co-pay per NYVEPRIA treatment, subject to a maximum benefit of $10,000 per calendar year for out-of-pocket expenses for NYVEPRIA including co-pays or coinsurances.
  • The amount of any benefit is the difference between your co-pay and $0.
  • After the maximum of $10,000 you will be responsible for the remaining monthly out-of-pocket costs.
  • Patient must have private insurance with coverage of NYVEPRIA.
  • This offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other private health or pharmacy benefit programs.
  • You must deduct the value of this assistance from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
  • You are responsible for reporting use of the program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the program, as may be required.
  • You should not use the program if your insurer or health plan prohibits use of manufacturer co-pay assistance programs.
  • This program is not valid where prohibited by law.
  • This program cannot be combined with any other savings, free trial or similar offer for the specified prescription.
  • Co-pay card will be accepted only at participating pharmacies.
  • This program is not health insurance.
  • This program is good only in the U.S. and Puerto Rico.
  • This program is limited to 1 per person during this offering period and is not transferable.
  • No other purchase is necessary.
  • Data related to your redemption of the program assistance may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other assistance redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke or amend this program without notice.
  • This program may not be available to patients in all states.
  • For more information about Pfizer, visit www.pfizer.com.
  • For more information about the Pfizer Oncology Together Co-Pay Savings Program for Injectables, visit pfizeroncologytogether.com, call 1-877-744-5675, or write to 
    Pfizer Oncology Together Co-Pay Savings Program for Injectables
    P.O. Box 220366
    Charlotte, NC 28222
  • Program terms and offer will expire at the end of each calendar year. Before the calendar year ends, you will receive information and eligibility requirements for continued participation.

   #For patients to be eligible for the Injectables Co-Pay Program for NYVEPRIA, they must have commercial insurance that covers NYVEPRIA and they cannot be enrolled in a state or federally funded insurance program. Whether a co-pay expense is eligible for the Injectables Co-Pay Program for NYVEPRIA benefit will be determined at the time the benefit is paid. Co-pay expenses must be in connection with a separately paid claim for NYVEPRIA administered in the outpatient setting.

   **The Injectables Co-Pay Program for NYVEPRIA will pay the co-pay for NYVEPRIA up to the annual assistance limit of $10,000 per calendar year per patient.

  ††The Injectables Co-Pay Program for NYVEPRIA provides assistance for eligible, commercially insured patients prescribed NYVEPRIA for co-pays or coinsurance incurred for NYVEPRIA up to $10,000 per calendar year. It does not cover or provide support for supplies, services, procedures, or any other physician-related services associated with NYVEPRIA treatment.





​​​​​​​References:

  1. ​​​​​​​​​​​​NYVEPRIA [prescribing information]. New York, NY: Pfizer Inc.; October 2021. 
  2. Data on file. Pfizer Inc.; New York, NY.
  3. US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Silver Spring, MD: FDA, US Dept of Health and Human Services; April 2015. Accessed March 22, 2022. https://www.fda.gov/media/82647/download.

 
NYVEPRIA is a trademark of Pfizer Inc.
Neulasta® (pegfilgrastim) is a registered trademark of Amgen Inc. 


 

Contraindications
  • NYVEPRIA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products
  • Reactions have included anaphylaxis
Warnings and Precautions
Splenic Rupture
  • Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products
  • Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving NYVEPRIA
Acute Respiratory Distress Syndrome (ARDS)
  • ARDS can occur in patients receiving pegfilgrastim products
  • Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving NYVEPRIA
  • Discontinue NYVEPRIA in patients with ARDS
Serious Allergic Reactions
  • Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products
  • The majority of reported events occurred upon initial exposure
  • Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti‐allergic treatment
  • Permanently discontinue NYVEPRIA in patients with serious allergic reactions
  • Do not administer NYVEPRIA to patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products
Use in Patients with Sickle Cell Disorders
  • Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products
  • Discontinue NYVEPRIA if sickle cell crisis occurs
Glomerulonephritis
  • Glomerulonephritis has occurred in patients receiving pegfilgrastim products
  • The diagnoses were based on azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy
  • Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products
  • If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of NYVEPRIA
Leukocytosis
  • White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products
  • Monitoring of complete blood count (CBC) during NYVEPRIA therapy is recommended
Thrombocytopenia
  • Thrombocytopenia has been reported in patients receiving pegfilgrastim products
  • Monitor platelet counts
Capillary Leak Syndrome (CLS)
  • CLS has been reported after granulocyte-colony stimulating factor (G‐CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration
  • Episodes vary in frequency and severity and may be life‐threatening if treatment is delayed
  • Patients who develop symptoms of CLS should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
  • The G-CSF receptor through which pegfilgrastim and filgrastim products act has been found on tumor cell lines
  • The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer
  • MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer
  • Monitor patients for signs and symptoms of MDS/AML in these settings
Aortitis
  • Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy
  • Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (eg, c-reactive protein and white blood cell count)
  • Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue NYVEPRIA if aortitis is suspected
Nuclear Imaging
  • Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results
Most Common Adverse Reactions
  • Bone pain
  • Pain in extremity

NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use

NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Please see full Prescribing Information, Patient Information, and Instructions for Use for NYVEPRIA.

Indication

NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

 
Limitations of Use
 

NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Please see full Prescribing Information, Patient Information, and Instructions for Use for NYVEPRIA.

    Please see full Prescribing Information.

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