What You Need to Know About Biosimilar Medicines

If you've been taking a biologic medicine for some time and your healthcare provider recommends that you start taking a biosimilar, it's not surprising that you may have questions. Starting with: What exactly is a biosimilar medicine?

A biosimilar is a biologic medicine (a type of medicine made from living cells) designed to work just like another Food and Drug Administration (FDA) approved biologic medicine, known as the reference product. Every biosimilar is tested to ensure it is highly similar to, and has no clinically meaningful differences from, the reference product before it is approved by the FDA. Biosimilar medicines are as safe and effective as the reference products available for chronic diseases including rheumatoid arthritis, Crohn's disease, ulcerative colitis and psoriasis.

To help you learn even more about biosimilars, we talked to a patient and a doctor who are intimately familiar with them. Here's what they had to say.

Biosimilar Medicines Are Biologics and Are Held to Rigorous Approval Standards

"Biosimilars are biologic medicines that have no clinically meaningful differences from their reference products in terms of safety and efficacy," says Jonathan Kay, MD, professor of medicine and of population and quantitative health sciences where he directs clinical research in the Division of Rheumatology.

Biosimilars need to meet thorough approval standards to ensure they are highly similar to their reference product and have no clinically meaningful differences.1

"I reassure my patients that each FDA-approved biosimilar has been studied extensively in comparison to its reference product and has been shown to be just as safe and effective," said Dr. Kay.

"I had concerns at first," noted Shelley, who lives with rheumatoid arthritis, a chronic inflammatory disorder that causes joint inflammation and pain. Shelley is currently on a biosimilar after switching from a reference product. "My main concern was efficacy. I wanted to know if it would work as well as the biologic I was already taking. But when I spoke with my doctor, he said a biosimilar is highly similar to its reference product which made me feel confident in switching."

The FDA ensures biosimilars are as safe and effective as their reference products by carefully reviewing data, studies, and tests that confirm the safety and effectiveness of the medicine.2

Starting a Biosimilar Should Not Impact Your Treatment Response

Biosimilars are expected to have the same effects as their reference products and can be a good option for anyone who has had success with a reference product.2

"I emphasize to patients that these medicines have been studied and reviewed extensively by the FDA and that approval has been granted only after careful consideration. There should be no difference between a patient's response to a biosimilar and that to its reference product," said Dr. Kay.

Each person is unique, so it is important that you speak with your healthcare provider about biosimilars, the available clinical data, and what treatment may work best for you.

Patient Support Programs Can Support the Transition to a Biosimilar

There are advocacy groups and support programs that aim to provide information to people taking a biosimilar. "I found that advocacy group websites, like Global Healthy Living Foundation, were a great resource for information about biosimilars," said Shelley.

Additionally, many pharmaceutical companies have patient support programs. For example, Amgen's support program, Amgen SupportPlus, provides patients who are on Amgen medicines with support services and resources.

How to Talk to Your Healthcare Provider About Biosimilars

Talk to your healthcare team to find out more about biosimilars. Below are a few questions to consider asking your healthcare team at your next appointment:

  1. My healthcare provider is recommending that I start a biosimilar. What does that mean for me and what do I need to know?
  2. How soon after starting can I tell if a biosimilar medication is working?
  3. Can I expect to pay the same amount at the pharmacy? Are there any patient support programs to help with out-of-pocket costs?
  4. Will starting a biosimilar impact my disease progression or my symptom management?
  5. How will the biosimilar be administered, and what support can I expect to help manage my treatment?
  6. Can I pick up my prescription at my current pharmacy?

While starting new medicines can be intimidating, Shelley recommends making a list of all your concerns and questions to bring with you to your doctor's appointment.

"This is something that I did when I switched to a biosimilar, and I still do this today. Having everything written down helps me have an open and honest conversation with my doctor," Shelley said.

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  1. Biosimilars: An Alternative to Biologics | Arthritis Foundation.
  2. US Food and Drug Administration. Biosimilar and interchangeable biologics: more treatment choices. Updated October 12, 2021. Accessed August 5, 2022.

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