Questions About Biosimilars – HealthyWomen

Biosimilars are drugs modeled after another type of drug called biologics. Both can be used to treat a variety of health issues, 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 proven to work as well and be just as safe as the biologic it’s modeled after (called a reference product).

Making medication from living material is a complex and time-consuming process, and the price tag 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 make — which means they cost patients less. On average, biosimilars are about one-third the price of the reference product.

If you are living with a health condition that can be managed with biologics, it’s possible that biosimilars could be a more affordable alternative that works just as well.

Here 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 HCP may not have the knowledge or experience needed to answer your questions about biosimilars. But they should be able to refer you to someone who can.

Are there any biosimilars available for my condition?

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

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

This price difference could be particularly helpful for women, since they are more likely than men to deal with chronic health conditions. Biosimilars may also offer women a more affordable alternative to a treatment that they might otherwise not be able to get, such as some expensive breast cancer treatments.

Will a biosimilar be covered by my insurance?

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

HCPs aren’t necessarily insurance experts, but most have experience helping patients navigate the process of figuring out which medications are covered.

Read: Barriers to Biosimilars >>

Is a biosimilar as effective as a biologic?

Biosimilars must be shown to work in the same way — and just as well — as the biologic reference product they’re modeled after before they can be approved by the FDA. Your HCP can give you information on how well the biosimilars they recommend for you work.

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 isn’t as simple as subbing a generic version of a drug for a brand-name one. (Both biosimilars and generics are copies of medications that have already been approved by the FDA, but biosimilars are only similar to their biologic reference products because they are large molecules made from living elements, while generics are the same as the brand-name drugs they copy because they are small molecules made from chemicals.)

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

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

Any time you’re considering a new medication, you’ll want to talk to your HCP about how this medication might interact with the ones you’re already taking. Bringing a list of all the medicines you’re taking (including over-the-counter ones such as allergy meds and supplements) can help your HCP get a clear picture of potential interactions with biosimilars.

What are the risks/side effects of the biosimilar you’re prescribing

The FDA has strict safety standards for medications, and biosimilars must be proven safe before they’re approved. But all medications carry a certain amount of 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’re considering treating with a biosimilar, but any other health conditions you’re dealing with.

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

Feeling empowered to find answers

It’s important to note that not every provider is an expert on biosimilars, and that’s okay. If your HCP isn’t able to answer these and other questions for you, you should feel empowered to ask for a referral to someone who can.


This educational resource was created with support from
Sandoz.

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