The U.S. Food and Drug Administration has approved biosimilar medications to treat conditions such as cancer, diabetes, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis, and more.
But what are biosimilar and interchangeable biosimilar biological medications? To answer that question, it helps to first know what biological products (biologics) are.
Biologics: Medications from Living Organisms
Biologics include medicines that generally come from living organisms, which can include animal cells and microorganisms, such as yeast and bacteria. That makes biologics different from conventional medications, which are commonly made from chemicals.
Unlike conventional medications, biologics generally cannot be made by following a chemical “recipe.” Because biologics generally come from living organisms, their nature varies, and their structures are generally more complex. Thus, developing biologics can be a more complicated process than manufacturing conventional drugs.
A biosimilar is a biologic that is highly similar to, and has no clinically meaningful differences from, another biologic that’s already FDA-approved (referred to as the reference product or original biologic). This means biosimilars:
- Are given the same way (same route of administration).
- Have the same strength and dosage form.
- Have the same potential side effects.
Biosimilars provide the same potential treatment benefits as the original biologic and are generally made with the same types of natural sources as the reference product.
Biosimilars Are Safe and Effective
Biosimilars are as safe and effective as the original biologic; both are rigorously and thoroughly evaluated by the FDA before approval. Before approving a biosimilar, FDA experts must conclude it is highly similar to and has no clinically meaningful differences from the original biologic. The FDA’s thorough evaluation ensures that all biosimilar products are as safe and effective as their reference products and meet the FDA’s high standards for approval. This means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would from the original product.
In addition, the FDA closely regulates the manufacturing of biosimilars. The same quality manufacturing standards that apply to the original biologic also apply to the biosimilar. It must be manufactured in accordance with Current Good Manufacturing Practice requirements, which cover:
- Controls for the manufacturing, processing, packaging, or holding of a drug product.
This helps to prevent manufacturing mistakes or unacceptable impurities and to ensure consistent product quality.
Interchangeable Biosimilar Medications
An interchangeable biosimilar product is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.
An interchangeable biosimilar product may be substituted without the intervention of the health care professional who prescribed the reference product, much like how generic drugs are routinely substituted for brand name drugs. This is commonly called pharmacy-level substitution and is subject to state pharmacy laws.
A health care provider also can prescribe an interchangeable biosimilar product just like they would prescribe a biosimilar or a reference product.
In July 2021, the FDA approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn), as a diabetes treatment. Semglee (insulin glargine-yfgn) is both biosimilar to and interchangeable with Lantus (insulin glargine).
The FDA expects to approve more interchangeable biosimilar products in the future. Because of the FDA’s high standards for approval, health care providers and patients can be confident in the safety and effectiveness of a biosimilar or an interchangeable biosimilar product, just as they would be for the FDA-approved original product.
Biologics are among the fastest growing segments of the prescription product market. The FDA approval of additional biosimilar and interchangeable biosimilar medications may help stimulate competition. Patients will have more treatment options and potentially less expensive alternatives.
You can search the Purple Book database for information about biological products, including biosimilar and interchangeable biosimilar products, approved by the FDA.