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Posted 12/06/2024
In a major shift in regulatory policy, the US Food and Drug Administration (FDA) is calling on Congress to remove the interchangeability designation that has historically set biosimilars apart in the US market. Backed by the Biden administration, the FDA's new proposal would permit pharmacy-level substitution of biosimilar drugs for reference products without clinician recommendation. This would extend to all approved biosimilars, regardless of their interchangeability status.
