What is the difference between Udenyca and Neulasta?
What is a biosimilar?
The US Food and Drug Administration (FDA) has approved Udencya as a biosimilar of Neulasta, which means it is "highly similar to, and has no clinically meaningful differences from" Neulasta - it is just as safe and effective and used in the same way.
A biosimilar product is like a generic version of a traditional drug. However, the difference between a biosimilar and a generic is that a biosimilar is not interchangeable with its reference product in the same way a generic version of a drug is.
Interchangeable biosimilar medications need to meet additional requirements and none have been approved by the FDA so far.
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 Neulasta used for?
Neulasta and Udenyca are leukocyte growth factors, which work as colony-stimulating factors to stimulate the production of neutrophils, a type of white blood cells.
Udenyca is used to reduce the number of infections, 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.
Neulasta is also approved for this use, as well as to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
- Food and Drug Administration (FDA). Purple Book Database of Licensed Biological Products. Simple Search Results for: Udenyca. Available from: https://purplebooksearch.fda.gov/results?query=pegfilgrastim&title=Udenyca. [Accessed February 17, 2021].
- Food and Drug Administration (FDA). Biosimilar and Interchangeable Biologics: More Treatment Choices. March 23, 2020. Available from: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices. [Accessed February 17, 2021].
- Food and Drug Administration (FDA). Udenyca. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761039s003lbl.pdf. [Accessed February 17, 2021].
- Food and Drug Administration (FDA). Neulasta. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125031s203lbl.pdf. [Accessed February 21, 2021].
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