Biden signs two bills to clarify new chemical entities, educate on biosimilars
President Joe Biden on Friday signed into law two FDA-related bills, including one to stop drugmakers from winning exclusivity for drugs that aren’t really new, and another to add new educational materials related to biosimilars online.
The new law on new chemical entities codifies the agency’s definition of an “active moiety” in the Food, Drug, and Cosmetic Act, previously known as S. 415. The law resolves any ambiguity between the FDA’s regulations and the statute, and makes clear that the definition of “active moiety” in FDA’s regulations should replace what the law previously described as an “active ingredient (including any ester or salt of the active ingredient).”
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