What is the difference between Udenyca and Fulphila?
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 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 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 used 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.
- Food and Drug Administration (FDA). Purple Book Database of Licensed Biological Products. Simple Search Results for: Fulphila. Available from: https://purplebooksearch.fda.gov/results?query=pegfilgrastim&title=Fulphila. [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].
- Food and Drug Administration (FDA). Fulphila. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761075s004lbl.pdf. [Accessed February 21, 2021].
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