• Opinion: The FDA just broke the logjam on interchangeable biologics. Here's what that decision means

    1 month ago - By STAT

    The Food and Drug Administration's decision on Wednesday to approve a long-acting insulin called Semglee 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 to substitute a biosimilar biologic for its brand-name product without the permission of the original prescriber...
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