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The Food and Drug Administration (FDA) has approved many biologics (also called biological products), which are medications generally made from living sources like bacteria and yeast. Biologics treat many conditions like arthritis, diabetes, kidney conditions, cancer, macular degeneration, and chronic skin and bowel diseases, such as psoriasis, Crohn’s disease and ulcerative colitis.
But biologics are often expensive and can be unaffordable, especially for people using several medications. If you’re currently using a biologic and you’re concerned about cost, you and your health care provider may want to talk about switching to a biosimilar.
A biosimilar is an FDA-approved biologic that is highly similar to and has no clinically meaningful differences from a biologic previously approved by FDA, which is sometimes described as the original biologic or reference product. Like generic drugs, biosimilars may save you money and are as safe and effective as the original biologic.
Some patients and health care providers might worry that biosimilars are not as safe or effective as the original biologic or that an interchangeable biosimilar is better than a biosimilar that is not an interchangeable biosimilar. Unwarranted concerns may discourage patients and their doctors from using or switching to a biosimilar, so it’s important to find out the facts.
How is a biologic like other drugs?
FDA-approved biologics, like other drugs FDA approves, are safe and effective medications for treating many illnesses. However, biologics are usually made from living sources such as proteins, living cells, and microorganisms such as bacteria or yeast. They usually are more complex than other drugs, and more complicate to make.
What is a biosimilar?
A biosimilar is a biologic that is highly similar to an original biologic already approved by the FDA. Both products are made from the same types of sources (such as living cells or microorganisms). Biosimilars also have no clinically meaningful differences from the original biologic. This means biosimilars are as safe and effective as the original biologic for their approved uses.
Is a biosimilar the same as a generic?
Biosimilars and generics are a lot alike. For example, both are versions of FDA-approved medicines and both may offer patients more affordable treatment options. Both also go through a rigorous review process at FDA. Once FDA approves biosimilars and generics, patients and their doctors can be confident that they are just as safe and effective as the products they’re compared to.
There are also some differences between biosimilars and generics. Generics can be easier to copy exactly because their active ingredients tend to be smaller and simpler, while biologics generally cannot be copied exactly, even between batches of the same brand, because their living sources can contain many slight variations. However, FDA requires biologic manufacturers, including biosimilar manufacturers, to carefully control and monitor for differences.
Should I be concerned if my doctor prescribes a biosimilar or wants to switch me from a reference product to a biosimilar?
No. FDA-approved biosimilars are as safe and effective as their original biologic and you can expect biosimilars to have the same benefits and risks as the original biologic. To be approved by FDA, companies show that patients on biosimilars don’t have any new or worsening side effects as compared to patients on the original biologic.
Your doctor may prescribe or switch you to a biosimilar for any number of reasons, including because it may be less costly, or the biosimilar might be covered by your insurance company.