What are Biosimilars?
A ‘biosimilar’ product is a medical product that is very similar to another already approved biological medicine. It is compared to its reference biologic that was manufactured with an original cell line. Since there is only one original cell line, the biosimilar manufacturer must create its own cell line. This can lead to minor differences, as it is not possible for another manufacturer to produce an identical one. It is, however, possible to create a biologic that is so close to the reference drug that it provides the same benefit. These are called biosimilars.
Some of the reference cancer treatments now have available biosimilar options.
Biosimilars are NOT the same as generic drugs. Generic drugs are made with identical chemicals to the reference drug and are small molecules. The biologic medications that biosimilars are patterned after are very large molecules. For example, monoclonal antibodies that are made from natural and living sources. Because of this, they cannot be made identical to the original drug.
The FDA requires many studies before a biosimilar can be approved. Before approval, the biosimilar must be similar to the original drug in these ways:
- Work in the body the same way;
- Achieve the same result;
- Be dosed and given in the same way; and,
- Show safety and effectiveness with no meaningful differences.
How do I know if a Biosimilar is right for me?
Choosing between a biologic and a biosimilar, like all treatment for colorectal cancer, should be made by the patient with their medical team.
Even if you are on the original drug and doing well, you might still consider a change in treatment based on a different cost. For a new patient, starting on the biosimilar would not be a treatment change and often costs less.
Reducing costs is one reason Congress created the FDA approval pathway for biosimilar medications. However, the FDA does not regulate whether insurance companies cover or reimburse the cost of biosimilars. If you have insurance, check with your insurance company to find out what is included in your plan. If you have a copay for medications, the cost to you may be lower if you and your doctor choose a biosimilar over the biologic reference product.
Biosimilars often come with patient support programs just like the original drug. Assistance, including financial, is available from the pharmaceutical companies that manufacture biosimilars and those who make the reference biologic.
Biosimilars can have benefits for the individual patients and the health care system. They offer patients a new option, which in turn increases competition in the healthcare market, lowers overall costs, and may offer lower out-of-pocket expenses back to patients.
There is no one right answer; ultimately, you should consider all options and work with your doctor to decide which treatment is right for you.
How do I know if I am on a Biosimilar?
Talk to your doctor and medical team about the medications you are taking. Biological medications, including biosimilars, are often given in a hospital or infusion center.
There are currently 28 biosimilars approved for nine original biologics. In colorectal cancer, the following biologics and biosimilars may be used:
Avastin (bevacizumab) reference biologic
The biosimilars are VEGF inhibitors used in metastatic colorectal cancer
- Mvasi (bevacizumab-awwb)
- Zirabev (bevacizumab-bvzr)
Epogen / Procrit (epoetin alfa) reference biologic
The biosimilar is given to boost red blood cells when someone is anemic
- Retacrit (epoetin alfa-epbx)
Neulasta (pegfilgrastim) reference product
The biosimilars are used to boost white blood cells to reduce the chance of infection
- Fulphila (pegfilgrastim-jmdb)
- Udenyca (pegfilgrastim-cbqv)
- Ziextenzo (pegfilgrastim-bmez)
- Nyvepria (pegfilgrastim-apgf)
Neupogen (filgrastim) reference product
The biosimilars are used to boost white blood cells to reduce the chance of infection.
- Zarxio (filgrastim-sndz)
- Nivestym (filgrastim-aafi)
What should I ask my doctor about Biosimilars?
Your doctor may be able to answer your questions or direct you to helpful resources and educational materials about biosimilars. Based on your medical history and diagnosis, your doctor will determine if a biosimilar is the most appropriate option to help treat your condition and manage your symptoms, whether you are new to therapy or currently taking a biologic.
Some questions you might want to ask include:
- Will the biosimilar work the same as the reference biologic that I’m currently on?
- Should I get the biosimilar option approved by my insurance company before I begin treatment?
- Can I expect any difference in the side effects with the biosimilar?
- Why are you recommending a biosimilar and not the reference drug?
- Is there financial assistance available from the biosimilar manufacturer?
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