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.
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. It is also approved to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Neulasta is approved for both these indications as well.
Is there any difference in the way they are administered?
In addition to a prefilled syringe and autoinjector, Udenyca is also available as an on-body injector (Udenyca Onbody), an innovative design that enables a five-minute infusion time.
Neulasta is available as a prefilled syringe and as Neulasta Onpro -- an on-body device that releases the drug over 45 minutes.
- Food and Drug Administration (FDA). Biosimilar and Interchangeable Biologics: More Treatment Choices. Updated 17 August 2023. Available from: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices.
- Neulasta Product Label. Revised 02/2021. https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/neulasta/neulasta_pi_hcp_english.pdf
- Udenyca Product Label. Revised 12/2023. https://udenyca.com/hcp/wp-content/pdfs/udenyca-pi.pdf
- Coherus Announces FDA Approval of Udenyca Onbody™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv. Dec 26, 2023. https://www.drugs.com/newdrugs/coherus-announces-fda-approval-udenyca-onbody-novel-proprietary-state-art-delivery-pegfilgrastim-6173.html
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