Fulphila (pegfilgrastim-jmbd), is a biosimilar to Neulasta (pegfilgrastim).
A biosimilar is a biological product that is highly similar to a biologic already approved by the FDA (known as the reference product) and has no clinically meaningful differences in terms of safety, purity and potency from the reference product. Biosimilars can provide cost-effective treatment options to already approved biologics.
Fulphila and Neulasta are used in cancer patients to boost the production of infection-fighting white blood cells and to help prevent neutropenia caused by chemotherapy. Neutropenia occurs when there is a low number of neutrophils, a type of white blood cell, found in the blood. Lower levels of white blood cells can increase your risk for infection and fever, especially during chemotherapy.
Neulasta, from Amgen, was the first pegfilgrastim agent approved by the FDA in 2002. Fulphila, from Mylan, was the first biosimilar to Neulasta and was approved in June 2018.
Are Fulphila and Neulasta the same?
Both Fulphila and Neulasta are in a drug class known as colony stimulating factors. Colony stimulating factors increase the production of white blood cells in response to infection. They stimulate the bone marrow to make more of the particular white blood cell (neutrophil). The new white blood cells migrate into the blood and fight the infection.
Pegfilgrastim is a “PEGylated” form of filgrastim (Neupogen). PEGylated means it is attached to a compound called polyethylene glycol (PEG). PEGylated forms of filgrastim can be given less frequently because they are removed from the body more slowly.
A list of FDA-approved biosimilars to Neulasta (pegfilgrastim) are:
- Fulphila (pegfilgrastim-jmdb)
- Fylnetra (pegfilgrastim-pbbk)
- Nyvepria (pegfilgrastim-apgf)
- Stimufend (pegfilgrastim-fpgk)
- Udenyca (pegfilgrastim-cbqv)
- Ziextenzo (pegfilgrastim-bmez)
Biosimilar names differ with extra letters added at the end of “pegfilgrastim” to help identify these products as biosimilars to the original.
More information: What Are Biosimilars? Top Facts You May Not Know
Is Fulphila given like Neulasta?
Unlike Fulphila, Neulasta can be given either as an injection from a prefilled syringe or by using the on-body injector (OBI) for Neulasta (Neulasta Onpro) for use at home, which your doctor can apply to your skin right after your chemo appointment.
- Twenty-seven hours after Neulasta Onpro has been placed on your skin, the on-body injector will automatically deliver a dose of Neulasta over a 45 minute period.
- After your dose is complete, you can remove the injector and dispose of it using the instructions your healthcare provider will supply.
Biosimilars for pegfilgrastim are not available with an on-body injector device at this time, which means you may need to go back to the clinic the next day for your injection. Your doctor may suggest that you can have your injection from a prefilled syringe given at home by you or your caregiver, after instructions. Speak to your healthcare provider about this option.
This is not all the information you need to know about Fulphila or Neulasta for safe and effective use. Review the full product information, and discuss this information with your doctor or other health care provider.