Questions About Biosimilars – HealthyWomen

Biosimilars are medications inspired by another type of drug called biological. Both can be used to treat a variety of health problems, including autoimmune conditions such as rheumatoid arthritis (RA) and some types of cancer.

Biologics are made from a natural source, such as plant or human cells, and biosimilars are made in the same way. To be approved by the FDA, a biosimilar must be shown to work as well and be as safe as the biological product that follows its model (called a reference product).

Making medicines from living material is a complex and time-consuming process, and the price of biologics reflects this. For example, biologics used to treat RA can cost up to $36,000 a year.

Because biosimilars are based on a biologic, they are easier and cheaper to manufacture, meaning they cost patients less. On average, biosimilars cost approximately one third the price of the reference product.

If you live with a health condition that can be managed with biologics, biosimilars may be a more affordable alternative that works just as well.

Below are some questions to ask your healthcare provider (HCP) about biosimilars.

What is your experience with biosimilars?

This is probably the first thing you should ask, because your doctor may not have the knowledge or experience to answer your questions about biosimilars. But they should be able to refer you to someone who can.

Are there biosimilars available for my condition?

Biosimilars can be used to treat or manage many chronic diseases, including diabetes, colitis, Crohn’s disease, psoriasis, arthritis, and multiple sclerosis. They are also used to treat breast, lung and colon cancer.

If you have one or more of these conditions, there may be a biosimilar that can help you. And if you’re already using a biologic to manage a health problem, a biosimilar could be a more affordable option.

This price difference could be especially helpful for women, as they are more likely than men to have to deal with chronic health conditions. Biosimilars can also offer women a more affordable alternative to a treatment they would not otherwise be able to receive, such as some expensive breast cancer treatments.

Will my insurance cover a biosimilar?

Which biosimilars (if any) will be covered depends entirely on your insurance plan and your unique health circumstances (your diagnosis, whether you have tried other treatments, etc.). For example, some insurance companies may choose to cover certain biologics instead of biosimilars because they have they made agreements with the manufacturers of these biological products.

Healthcare professionals are not necessarily insurance experts, but most have experience helping patients navigate the process of determining which medications are covered.

Read: Barriers to biosimilars >>

Is a biosimilar as effective as a biologic?

Biosimilars must be shown to work as well (and as well) as the reference biological product on which they are based before they can be approved by the FDA. Your doctor can give you information about how well the biosimilars they recommend work for you.

How do I safely switch from a biologic to its biosimilar?

Because biosimilars are similar, but not identical, versions of biologics, switching from a biologic to a biosimilar is not as simple as substituting a generic version of a drug for a brand-name one. (Both biosimilars and generics are copies of drugs that have already been approved by the FDA, but biosimilars are only similar to their reference biologic products because they are large molecules made from living things, while generics are the same as drugs because they are small molecules made of chemicals.)

That said, a recent review of several studies including more than 5,000 patients who switched between biologics and biosimilars found no difference in safety between the two. Your doctor can guide you through the process and will check that your body is reacting well to the change.

How will the biosimilar interact with other medications I am currently taking?

Any time you are considering a new medication, you will want to talk to your doctor about how this medication might interact with those you are already taking. Keeping a list of all the medications you are taking (including over-the-counter medications, such as allergy medications and supplements) can help your doctor get a clear picture of potential interactions with biosimilars.

What are the risks/side effects of the biosimilar you are prescribing?

The FDA has strict safety standards for drugs, and biosimilars must be proven safe before they are approved. But all medications carry some risk and/or have the potential to cause side effects. Much depends on the specific medication and your current health situation, not just the condition you are considering treating with a biosimilar, but any other health conditions you are dealing with.

A biosimilar will have the same risks/side effects as the biologic for which it is designed. Your doctor can help you understand the possible risks and side effects of biosimilars based on your unique health situation.

Feel empowered to find answers

It’s important to note that not all providers are biosimilar experts, and that’s okay. If your doctor cannot answer these and other questions for you, you should feel empowered to request a referral to someone who can.


This educational resource was created with the support of
Sandoz.

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