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Coherus BioSciences

Coherus BioSciences is committed to providing choice without compromise

Who is Coherus BioSciences?

We are dedicated to improving access to biologic drugs through high-quality, high-value biosimilar therapies because we believe that bringing more choice—and competition—to the marketplace can help address rising healthcare costs and lower the financial burden of care.

At Coherus, we manufacture UDENYCA® with a commitment to high quality, not high cost.

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Our promise

To offer those in need, whose viability depends on it—patients, healthcare professionals, institutions, and payers—the opportunity to choose the healthcare that will benefit patients the most.

  • Coherus has brought to market a new standard of competition, embracing change and equalizing opportunities so that everyone can win
  • We are continuing to challenge the complacency of the status quo by listening closely, acting with purpose and passion, and holding ourselves and our peers to a higher standard
  • While our products are biosimilars, there is nothing similar about the way we do business. By challenging current standards, we are creating disruption for the greater good by offering choice without compromise

Manufactured in the USA

Coherus manufactures UDENYCA® in Boulder, Colorado. Our facilities have undergone rigorous examination and have successfully passed FDA inspections. Our process meets the highest standards and ensures both product quality and availability.

Learn more at coherus.com

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.

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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®.
  • 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 healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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