In November, Independence Blue Cross (IBX) will be announcing changes to the preferred status for Humira® and several of its biosimilars. This is the first in a series of articles intended to provide information and awareness about biosimilars for health care professionals across our network.
The U.S. Food & Drug Administration (FDA) has made biosimilar education a priority in recent years. Biosimilars are safe and effective biological medications for treating many conditions, including chronic skin diseases (such as psoriasis), inflammatory bowel diseases (such as Crohn's disease and ulcerative colitis), rheumatoid arthritis, diabetes, and cancer.
A biosimilar has no clinically meaningful differences from the original FDA-approved biologic, called a reference product. Biosimilars are made with the same types of living sources, are administered via the same route, and have the same strength, dosage, treatment benefits, and potential side effects as the reference product. See
Overview of Biosimilar Products (fda.gov) for a brief review on biosimilars.
The main difference between biosimilars and generic drugs is that the active ingredients of generic drugs are chemical compounds that are generally smaller, simpler, and more straightforward to copy. The active ingredient in generic medications are exact replicas of the brand product.
Biologics generally cannot be copied exactly, because these products are produced from living organisms which results in a mix of many slight variations of a protein, and this mix is never exactly the same in each batch of the product. Thus, a biosimilar is very similar, but not identical, to the reference product.
For this reason, biosimilar manufacturers must submit data to the FDA for approval showing that their products have similar variations compared to their reference, brand-name biologic, and that their biosimilar products have no clinically meaningful differences in terms of safety, quality, and effectiveness.
Visit
www.FDA.gov to learn more.
What is a Biosimilar?