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Biosimilar Basics

Learn how biosimilars such as UDENYCA® reduce treatment costs and increase patient access

What is a biosimilar?

A biosimilar is an 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
Watch a short video to learn more about biosimilars.
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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, which may have minor differences
  • No clinically meaningful differences in terms of the safety, purity, and potency
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, which may have minor differences
  • No clinically meaningful differences in terms of the safety, purity, and potency
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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

external link icon Biosimilar information
from the FDA
Learn More
external link icon Biosimilar information from
the Cancer Action Network
Learn More

How UDENYCA® works for you

UDENYCA® is an effective and affordable pegfilgrastim biosimilar treatment

Learn More

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) Patient Information. Redwood City, CA: Coherus BioSciences, Inc.; 2023.

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. U.S. Food and Drug Administration. Updated April 27, 2023. Accessed on April 27, 2023. 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, et al. Cost of cancer-related neutropenia or fever hospitalizations. 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) Patient Information. Redwood City, CA: Coherus BioSciences, Inc.; 2023.

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) Patient Information. Redwood City, CA: Coherus BioSciences, Inc.; 2023.

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) Patient Information. Redwood City, CA: Coherus BioSciences, Inc.; 2023.

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)Patient Information. Redwood City, CA: Coherus BioSciences, Inc.; 2023.

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 not to miss this appointment, so discuss any transportation questions you may have with your healthcare team prior to treatment.

References: 1. Biological product definitions. U.S. Food and Drug Administration. Accessed April 27, 2023. 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) Patient Information. Redwood City, CA: Coherus BioSciences, Inc.; 2023. 4. The Issue - Why Biosimilars. Biosimilars Forum. https://biosimilarsforum.org/why-biosimilars/the-issue/. Accessed on April 27, 2023. 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 on April 27, 2023. https://www.rand.org/news/press/2017/10/23.html
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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.

IMPORTANT SAFETY INFORMATION

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

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®.
  • Decreased platelet count (thrombocytopenia). Your healthcare provider will check your blood during treatment with UDENYCA®. Tell your healthcare provider if you have unusual bleeding or bruising during treatment with UDENYCA®. This could be a sign of decreased platelet counts, which may reduce the ability of your blood to clot.
  • 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
  • Myelodysplastic syndrome and acute myeloid leukemia. If you have breast cancer or lung cancer, when UDENYCA® is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with UDENYCA®.
  • 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.
  • Bone imaging (Nuclear Imaging): The formation of certain blood cells may increase and can be associated with short term changes in bone imaging. Your doctor should consider this whne interpreting bone imaging results.

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 healthcare provider for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or notify the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

Please read the Patient Information for UDENYCA®, and discuss it with your doctor. The physician Prescribing Information is also available.

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