The U.S. Food and Drug Administration’s (FDA) approval of a biosimilar drug late this summer, points to a new direction in more affordable specialty drugs.
Biologics are unlike conventional medications, as they generally come from living organisms rather than a chemical recipe, requiring a more complicated process to produce. Many biosimilar medications have been FDA-approved to treat diseases such as cancer, diabetes, Crohn’s disease, colitis, rheumatoid arthritis, psoriasis and more. An interchangeable biosimilar product meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.
According to the FDA, an interchangeable biosimilar 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.
While there are currently 31 biosimilar medications on the market, in July 2021, the FDA approved the first interchangeable biosimilar product, Semglee (insulin glargine-yfgn), as a diabetes treatment. Semglee is both biosimilar to and interchangeable with Lantus (insulin glargine).
The FDA expects to approve more interchangeable biosimilar products in the future and, in doing so, may spark competition, allowing for more treatment options and potentially less expensive alternatives.
