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What is UDENYCA®?

UDENYCA® is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

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Biosimilar Basics

Learn how biosimilars such as UDENYCA® are changing healthcare

What is a biosimilar?

A biosimilar is a safe, effective, and affordable treatment alternative to an existing reference biologic. Biologics are generally large, complex molecules and, unlike other drugs, are made from living cells.1
genetics icon Biosimilars are not the same as generics. Unlike generics, which are made from chemical processes to match an original branded treatment, biosimilars are made from living cells. Because of this, no two batches are exactly the same. A biosimilar is a highly similar version of a reference biologic, with no clinically meaningful differences in safety, purity, or effectiveness.1

Understanding the differences in originators, generics, reference biologic products, and biosimilars.

We can describe the differences between originators, generics, reference biologic products, and biosimilars by using the analogy of the differences between a bicycle (representing originators and generics) and a tree (representing reference biologic products and biosimilars).

Original branded treatment1,2

  • Made of dozens or hundreds of pieces and parts
  • Can be reproduced exactly the same every time
bike icon

Generic1,2

  • Made of dozens or hundreds of pieces and parts
  • Key components can be reproduced and delivered exactly the same as the originator
bike icon

Reference biologic1,2

  • Made from a living system
  • Made of thousands of parts
  • Cannot be replicated exactly the same every time
tree icon

Biosimilar1,2

  • Highly similar to the reference biologic product
  • No clinically meaningful differences in terms of the safety, purity, and potency
minor differences tree icon
To gain FDA approval, biosimilars must prove similarity and demonstrate no clinically meaningful differences to the already approved reference biologic product. UDENYCA® is an FDA-approved biosimilar to the biologic treatment Neulasta® (pegfilgrastim).1,3
bike icon

Original branded treatment1,2

  • Made of dozens or hundreds of pieces and parts
  • Can be reproduced exactly the same every time
bike icon

Generic1,2

  • Made of dozens or hundreds of pieces and parts
  • Key components can be reproduced and delivered exactly the same as the originator
tree icon

Reference biologic1,2

  • Made from a living system
  • Made of thousands of parts
  • Cannot be replicated exactly the same every time
tree icon

Biosimilar1,2

  • Highly similar to the reference biologic product
  • No clinically meaningful differences in terms of the safety, purity, and potency
minor differences
to previous slide to next slide
To gain FDA approval, biosimilars must prove similarity and demonstrate no clinically meaningful differences to the already approved reference biologic product. UDENYCA® is an FDA-approved biosimilar to the biologic treatment Neulasta® (pegfilgrastim).1,3

The high value of biosimilars

down percent icon Biosimilar medicines have driven down the cost of treatments by introducing competition, making medications more accessible for patients.4,5
money icon Biosimilars are often lower priced than the biologic treatment, and have been projected to cut healthcare spending in the US by $54 billion over the next decade.6

Helpful resources

Frequently asked questions

What is UDENYCA®?

 

UDENYCA®, a biosimilar treatment, is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection.

Source: UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019.

What are biosimilars?

 

Biosimilars are FDA-approved biologic medications that are as safe and effective as the original biologics (known as the reference product). Biosimilars have no clinically meaningful differences from the reference product. This means that there is no compromise in safety and effectiveness of the biosimilar when compared to the reference product. Biosimilars introduce competition into the marketplace and can lower the cost of cancer-related treatment.

Source: Biosimilar and interchangeable products. US Food and Drug Administration. Updated October 23, 2017. Accessed May 12, 2020. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products#nodiff

Why does chemotherapy cause low white blood cell counts?

 

Chemotherapy works by targeting cancerous cells. It can also affect and lower healthy cell counts, including the white blood cells that fight infections.

Source: Tai E, Guy GP, Dunbar A, Richardson LC. Cost of cancer-related neutropenia or fever hospitalizations, United States, 2012. J Oncol Pract. 2017;13(6):e552-e561.

Who should not take UDENYCA®?

 

Do not take UDENYCA® if you have had a serious allergic reaction to human G-CSFs such as pegfilgrastim or filgrastim products.

Source: UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019.

What should I tell my healthcare provider before taking UDENYCA®?

 

Before you receive UDENYCA®, tell your healthcare provider about all of your medical conditions, including if you have a sickle cell disorder, have kidney problems, are pregnant or plan to become pregnant (it is not known if UDENYCA® will harm your unborn baby), are breastfeeding or plan to breastfeed (it is not known if UDENYCA® passes into your breast milk).

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

Source: UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019.

What are the most common side effects of UDENYCA®?

 

The most common side effects of UDENYCA® are pain in the bones, arms, and legs. These are not all the possible side effects of UDENYCA®. Talk with your doctor about managing bone pain and any other side effects. Be sure to review the Patient Information for more side effect information.

Source: UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019.

How will I receive UDENYCA®?

 

UDENYCA® is given as an injection under your skin (subcutaneous injection) by a healthcare provider the day after chemotherapy treatment.

Source: UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019.

Do I return to my physician’s clinic the day after treatment?

 

You will need to return to your healthcare provider the day after chemotherapy to receive UDENYCA®. It’s important to not miss this appointment, so discuss any transportation questions you may have with your healthcare team prior to treatment.


References: 1. Biological product definitions. US Food and Drug Administration. Accessed May 12, 2020. https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf 2. Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin. 2012;28(6):1053-1058. 3. UDENYCA® (pegfilgrastim-cbqv) package insert. Redwood City, CA: Coherus BioSciences, Inc.; 2019. 4. Biosimilars. US Food and Drug Administration. Updated February 3, 2020. Accessed May 12, 2020. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars 5. US Bureau of Labor Statistics. Medi-Span Price Rx, 2018. 6. Biosimilar drugs may reduce U.S. health spending by $54 billion over next decade. News release. Rand Corporation. October 23, 2017. Accessed May 12, 2020. https://www.rand.org/news/press/2017/10/23.html
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IMPORTANT SAFETY INFORMATION

Do not take UDENYCA if you have had a serious allergic reaction to pegfilgrastim or filgrastim products.

Before you receive UDENYCA, tell your healthcare provider about all of your medical conditions, including if you:

  • have a sickle cell disorder.
  • have kidney problems.
  • are pregnant or plan to become pregnant. It is not known if UDENYCA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if UDENYCA passes into your breast milk.

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

How will I receive UDENYCA?

  • UDENYCA is given as an injection under your skin (subcutaneous injection) by a healthcare provider. If your healthcare provider decides that the subcutaneous injections can be given at home by you or your caregiver, follow the detailed "Instructions for Use" that comes with your UDENYCA for information on how to prepare and inject a dose of UDENYCA.
  • You and your caregiver will be shown how to prepare and inject UDENYCA before you use it.
  • You should not inject a dose of UDENYCA to children weighing less than 45kg from a UDENYCA prefilled syringe. A dose less than 0.6 mL (6mg) cannot be accurately measured using the UDENYCA prefilled syringe.
  • If you are receiving UDENYCA because you are also receiving chemotherapy, the last dose of UDENYCA should be injected at least 14 days before and 24 hours after your dose of chemotherapy.
  • If you miss a dose of UDENYCA, talk to your healthcare provider about when you should give your next dose.

What are possible side effects of UDENYCA?
UDENYCA may cause serious side effects, including:

  • Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.
  • A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provider or get emergency care right away if you have shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.
  • Serious allergic reactions. UDENYCA can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using UDENYCA and call your healthcare provider or get emergency medical help right away.
  • Sickle cell crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and receive UDENYCA. Serious sickle cell crises have happened in people with sickle cell disorders receiving pegfilgrastim that has sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.
  • Kidney injury (glomerulonephritis). UDENYCA can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:
    • swelling of your face or ankles
    • blood in your urine or dark colored urine
    • you urinate less than usual
  • Increased white blood cell count (leukocytosis). Your healthcare provider will check your blood during treatment with UDENYCA.
  • Capillary Leak Syndrome. UDENYCA 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. Get emergency medical help right away if you develop any of the following symptoms:
    • swelling or puffiness and are urinating less than usual
    • trouble breathing
    • swelling of your stomach-area (abdomen) and feeling of fullness
    • dizziness or feeling faint
    • a general feeling of tiredness
  • Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel that transports blood from the heart to the body) has been reported in patients who received pegfilgrastim. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms.

The most common side effects of UDENYCA are pain in the bones, arms, and legs. These are not all the possible side effects of UDENYCA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store UDENYCA?

  • Store UDENYCA in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Do not freeze. If UDENYCA is accidentally frozen, allow the prefilled syringe to thaw in the refrigerator before injecting.
    • Do not use a UDENYCA prefilled syringe that has been frozen more than 1 time. Use a new UDENYCA prefilled syringe.
  • Throw away (dispose of) any UDENYCA that has been left at room temperature, 68°F to 77°F (20°C to 25°C), for more than 48 hours or frozen more than 1 time.
  • Keep the prefilled syringe in the original carton to protect from light.
  • Do not shake the prefilled syringe.
  • Take UDENYCA out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.

Keep the UDENYCA prefilled syringe out of the reach of children.

General information about the safe and effective use of UDENYCA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use UDENYCA for a condition for which it was not prescribed. Do not give UDENYCA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about UDENYCA that is written for health professionals.

What are the ingredients in UDENYCA?

Active ingredient: pegfilgrastim-cbqv

Inactive ingredients: acetate, polysorbate 20, sodium, and sorbitol in Water for Injection.

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