Opinion: The FDA just broke the logjam on interchangeable biologics. Here’s what that decision means
The Food and Drug Administration’s decision on Wednesday to approve a long-acting insulin called Semglee (insulin glargine-yfgn) as the first interchangeable biologic licensed for the U.S. market represents a major step forward to greater competition and access for patients. What it means in practice, however, depends on where you sit.
The term “interchangeable” sounds simple but is defined by law as a set of requirements to be evaluated by the FDA. The interchangeable designation allows pharmacists (subject to state law) to substitute a biosimilar biologic for its brand-name (reference) product without the permission of the original prescriber, much as occurs today for generic drugs.
