Pegfilgrastim Biosimilars: What to Know About Fulphila and Other Neulasta Look-Alikes
Key takeaways:
Neulasta (pegfilgrastim) is a biologic medication that helps prevent issues like infection after chemotherapy or radiation.
Biosimilars are “highly similar” to other biologics — kind of like generic versions of brand-name products. Neulasta’s biosimilars offer the same benefits and risks as Neulasta, but the biosimilars are generally more affordable.
There are currently six FDA-approved biosimilars to Neulasta. Udenyca, Ziextenzo, and Fulphila are three such biosimilars. Your insurance status will likely be the deciding factor on whether you receive Neulasta or a particular biosimilar.
Table of contents
Chemotherapy continues to have an important role in fighting cancer. It works quickly to kill cancer cells, but isn’t very specific. It doesn’t have great aim. It can accidentally harm cancer cells and healthy cells. As a result, healthy cells — like white blood cells that fight infection — sometimes need reinforcements.
This is where biologic medications, called colony-stimulating factors, come in. Neulasta (pegfilgrastim) is the long-lasting form we’ll discuss here. There’s also a short-acting form called Neupogen (filgrastim) that works in a similar way.
Neulasta helps alleviate blood-related side effects of cancer treatments. It can be used after chemotherapy for both solid tumors and blood cancers. And since Neulasta is so important, a handful of biosimilars have been developed to improve access to the medication.
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What is Neulasta?
Chemotherapy can cause neutropenia, which is when your white blood cell counts drop too low. With low numbers of white blood cells available to defend your body against germs and other invaders, you're at a higher risk of developing an infection or sepsis — especially if you’re “neutropenic” and have a fever (e.g. febrile neutropenia).
Neulasta is the original version (“reference product”) of the biologic medication pegfilgrastim. First approved in 2002, it was developed to help decrease the risk of infection from febrile neutropenia or high doses of radiation. It’s given as a single-dose injection under the skin (subcutaneously) when it’s needed. Since it is a long-acting medication, it’s injected once after chemotherapy and its effects last for several days.
Neulasta vs. pegfilgrastim biosimilars
Neulasta was the lone pegfilgrastim product available in the U.S. for about 16 years. Then, the first Neulasta biosimilar, Fuphila, was approved in 2018.
You can think of biosimilars as generic versions of reference biologics. Biologics and biosimilars are medications that come from living sources, and they’re often used to manage hard-to-treat health conditions. But because they’re complicated to make, it’s not possible to make exact copies of them. This is why biosimilars are “highly similar” — and not exactly the same — as their reference products. They only have minor, clinically insignificant differences. The FDA also has strict rules about what counts as highly similar.
Neulasta currently has six biosimilars. These biosimilars are similarly safe and effective as Neulasta, but they’re generally more affordable. We’ll discuss these six biosimilars more below.
1. Fulphila
Fulphila (pegfilgrastim-jmdb) was the first ever biosimilar to Neulasta. It was approved in June 2018. It’s approved to decrease the risk of infection from febrile neutropenia.
A study comparing the effectiveness and safety of Fulphila to Neulasta found that the medications had similar outcomes. It’s available as a prefilled syringe.
2. Udenyca
Udenyca (pegfilgrastim-cbqv) was approved a few months after Fulphila. Like other biosimilars, studies show that there are no meaningful differences between the Udenyca and Neulasta when it comes to their structure, how they target white blood cells, and how they work once they’re inside your body.
Udenyca is available as a prefilled syringe, but it also comes as an auto-injector for easier administration. More on this later.
3. Ziextenzo
Ziextenzo (pegfilgrastim-bmez) was approved in November 2019. Ziextenzo was developed and approved following the same, strict FDA guidelines for biosimilar development. A study showed that the effects of Ziextenzo were not clinically different than Neulasta’s. It also comes as a prefilled syringe.
4. Nyvepria
Nyvepria (pegfilgrastim-apgf) was approved in June 2020. The manufacturer completed studies to prove that Nyvepria is highly similar to Neulasta, but they were not published or made available for public viewing. Like the other Neulasta biosimilars, Nyvepria comes as a prefilled syringe.
5. Fylnetra
Fylnetra (pegfilgrastim-pbbk) was approved in June 2022. If you need pegfilgrastim, it’s another prefilled syringe to consider.
Similar to Nyvepria, data proving that Fylnetra is highly similar to Neulasta was submitted to the FDA. Specific insights, however, haven’t been published.
6. Stimufend
Stimufend (pegfilgrastim-fpgk) was approved in September 2022 as another version of pegfilgrastim. It comes in a prefilled syringe, and it’s the sixth and most recent Neulasta biosimilar to hit the market. A published study shows that Stimufend has similar characteristics to Neulasta, supporting its case for biosimilarity.
What to know about pegfilgrastim autoinjectors
As mentioned, Neulasta and its biosimilars are available in prefilled syringes. Each dose is injected under the skin. This can be done at home by yourself, a friend, or family member. It can also be given in the clinic by a healthcare provider.
However, syringes aren’t the only way to administer pegfilgrastim. A couple of other options are also available.
Neulasta is available in a small device called Neulasta Onpro. This small, patch-like autoinjector is placed on your skin while you’re at the clinic, and the dose is automatically injected 27 hours later. After the dose is given, you can take the patch off by yourself. This is a good option if you don’t like the idea of administering an injection by yourself.
A second autoinjector, Udenyca Autoinjector, was recently approved in March 2023. But unlike Neulasta Onpro, this autoinjector isn’t a patch. It’s a pen that automatically injects medication by pushing the tip of it against the skin. It works similarly to an EpiPen.
How to choose the best pegfilgrastim biosimilar
It’s hard to say if one Neulasta biosimilar is better than the rest. They haven’t been directly compared to one another. But since they’re all considered highly similar to Neulasta, the Neulasta biosimilar you’d receive is typically dictated by the preferences of your cancer center and insurance plan. Your healthcare provider can safely decide to give you one or another depending on the situation and what they have available.
Cancer center
If you’re receiving pegfilgrastim at a clinic, your cancer center may only keep certain biosimilars in stock. Your healthcare team will decide which product may be best for you based on their expertise, your preferences, and your insurance coverage status. It’s difficult — financially and logistically — to keep all seven versions of pegfilgrastim readily in stock.
Insurance coverage
No matter if you’re receiving Neulasta or a biosimilar, your insurance plan will likely have a preferred product. This preference is based on their drug formulary: a list of specific medications that your insurance plan will cover.
Insurance plans will typically cover at least one biosimilar. The biosimilar that is covered is considered a “formulary” option. If it is not covered, it’s considered “non-formulary” and will typically have higher out-of-pocket costs. In these cases, your healthcare provider will recommend taking the product that’s covered.
Sometimes, Neulasta or a biosimilar is covered by insurance, but it still has a high copay. If you have a high copay, there may be some ways to save through manufacturer copay programs. Some examples include Amgen’s first step program for Neulasta, Coherus’ Copay savings program for Udenyca, and Sandoz’s one source program for Ziextenzo.
Little or no insurance
If you’re underinsured or don’t have insurance, patient assistance programs are a key resource for financial support. For example, Amgen Assist is a program that helps eligible patients obtain Neulasta if you don’t have insurance or if your insurance doesn’t cover any biosimilar.
Let your healthcare provider know if you are worried about copays to see what options you have.
The bottom line
Neulasta is a biologic medication that helps prevent neutropenia and infection from different cancer treatments. It also has six biosimilars available, including Fulphila, Udenyca, and Ziextenzo. Neulasta’s biosimilars are considered “highly similar” to Neulasta. Your insurance plan and cancer center will primarily determine which biosimilar you will receive.
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References
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