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Purple Book Changes May Not Go Far Enough, Generics Bulletin

June 24, 2021

Excerpts of an As Prescribed blog post written recently by Jacqueline Berman and Maria Kalousi-Tatum were cited in a Generics Bulletin article on new requirements coming into effect this month for the US Food and Drug Administration’s (FDA) Purple Book. Despite the requirement that additional details be included in the guide, Jacqueline and Maria write that information gaps for biosimilars developers may still exist. Among their observations about the revamped Purple Book quoted by the article, “There is no obligation for product sponsors to keep patent information in the Purple Book current. Accordingly, subsequent applicants should not solely rely on the Purple Book when trying to understand potential patent challenges under FDA’s statutes.”

Read the complete Generics Bulletin article >>