What is the difference between Udenyca and Fulphila?

Medically reviewed by Carmen Pope, BPharm. Last updated on Feb 13, 2024.

Official Answer by Drugs.com

Udenyca (pegfilgrastim-cbqv) and Fulphila (pegfilgrastim-jmdb) are both biological drugs containing pegfilgrastim. Udenyca and Fulphila are biosimilars of the reference product Neulasta (pegfilgrastim).

The US Food and Drug Administration (FDA) approved Udencya and Fulphila as biosimilars of Neulasta in 2018, which means that each one is "highly similar to, and has no clinically meaningful differences from" Neulasta. Udencya and Fulphila are as safe and effective as Neulasta and are used in the same way.

A biosimilar of a biological drug is like a generic of a traditional drug. However, the difference between a biosimilar and a generic is that a biosimilar is not interchangeable with its reference product. So while Udenyca, Fulphila and Neulasta contain the same active ingredient they are not interchangeable. Interchangeable biosimilar medications need to meet additional requirements.

Biological drugs are large molecule drugs that are typically produced in living organisms, unlike traditional small molecule drugs made from chemicals. They are more complex to make than traditional drugs, and they have more complex structures and their nature can vary.

For more information, see What Are Biosimilars? Top Facts You May Not Know

What are Udenyca and Fulphila used for?

Udenyca and Fulphila are leukocyte growth factors, which work as colony-stimulating factors to stimulate the production of neutrophils, a type of white blood cells.

Udenyca and Fulphila are both FDA-approved to reduce the number of infections, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Udenyca is also FDA-approved to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Are there any differences in the way they are administered?

Both are administered subcutaneously (under the skin). Udenyca is available in three different injection types:

6 mg/0.6 mL in a single-dose prefilled syringe for manual use only
6 mg/0.6 mL in a single-dose prefilled autoinjector
6 mg/0.6 mL in a single-dose prefilled syringe co-packaged with the onbody injector for Udenyca.

Fulphila is only available as a 6 mg/0.6 mL single-dose prefilled syringe for manual use only.

References

Food and Drug Administration (FDA). Biosimilar and Interchangeable Biologics: More Treatment Choices. Updated 08/2023.. Available from: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices
Udenyca Product Information. Updated 12/2023. Udenyca.com https://udenyca.com/hcp/wp-content/pdfs/udenyca-pi.pdf
Fulphila Product Information. Updated 06/2023. Biocon Biologics US https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=9bfc4d3e-6120-7fec-f1d6-0b3743752034&type=display

Is Fulphila a chemo drug?

No, Fulphila is a prescription medicine used to boost the number of white blood cells in cancer patients receiving chemo. Fulphila is a man-made form of a protein known as a colony stimulating factor used to help prevent neutropenia (low white blood cells) caused by chemotherapy. Continue reading

What does cbqv stand for in pegfilgrastim?

The “cbqv” suffix is found in the biosimilar name for Udenyca (pegfilgrastim-cbqv), a biologic drug used to prevent neutropenia (a lack of certain white blood cells) caused by receiving chemotherapy. The suffix is used to distinguish its name from the original reference product, in this case Neulasta (pegfilgrastim), which has no suffix. The suffix on biosimilars helps healthcare providers and patients realize the medicine is an approved biosimilar, but the suffix has no specific meaning itself. Continue reading

What are biosimilar drugs and how do they compare to biologics?

A biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. The most recently approved biosimilar is Starjemza (ustekinumab-hmny), an interchangeable biosimilar to Stelara, cleared by the FDA on May 22, 2025.

What is the difference between Udenyca and Fulphila?

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What are Udenyca and Fulphila used for?

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