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.

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

Related questions

• What is the difference between Fulphila and Neulasta?
• What is the difference between Udenyca and Neulasta?
• How is Fulphila injected / administered?

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.