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Understanding Biosimilar Medications

This post is part of our “Ask an Expert” blog series. In this post, Ken Majkowski, Pharm.D and Chief Pharmacy Officer at FamilyWize , explains what biosimilars are and when they should be considered. Ken brings more than 40 years of healthcare experience to the FamilyWize team, including 14 years of clinical pharmacy experience in retail, hospital and home care. Read his full bio, here .

Generic medications come up fairly regularly in conversations about prescription drugs. Depending on what types of treatment you need, you may also hear about “biosimilar” products.

What They Are

Some conditions are treated with a drug called a biologic. A biologic drug is a product that is produced from living organisms or contains components of living organisms. These products are administered by injection or infusion and often have to be stored carefully, at specific temperatures for example, to maintain their effectiveness.

A biosimilar product has been created to “match” an existing biologic product, or its “reference product.” An FDA-approved biosimilar has no clinically meaningful differences from it’s FDA-approved reference product, although there may be differences in the formulation of the product. They are safe and regulated by the FDA, just like any other prescription drug option. However, in rare cases, a biosimilar may produce an allergic type reaction whereas the reference will not. In this case, the reference product can be used. As of October 2017, FDA has approved seven biosimilars, and some are already on the market.

Who Might Use a Biosimilar

If you are already taking a biologic, an FDA-approved biosimilar might provide you with a more affordable treatment option. Currently, biosimilars are used in the treatment of autoimmune diseases, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, and ulcerative colitis. They also help patients with certain types of colorectal, lung, breast, and other types of cancer. Even if you are not currently able to purchase a biosimilar product, experts expect the existence of biosimilars to increase market competition and begin driving down the price of existing biologic treatments – similar to the way generics affected the United States’ drug market years ago.

If you or a loved one has been prescribed a biologic, take a few minutes to discuss your treatment options with your prescribing doctor and pharmacist. New products are being approved each year, so if your biologic doesn’t have a biosimilar yet, it may in the future.

Curious to learn more? The FDA has created this webpage full of downloadable information to spread the word.


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