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/PRNewswire/ -- Amgen (NASDAQ:AMGN) today released the 9th edition of its Biosimilar Trends Report, which examines the current and future state of the U.S....
16.08.2022 - DGAP-News: Formycon AG / Key word(s): Study results/Study Formycon's Biosimilar Ustekinumab Candidate FYB202 Shows Comparable Efficacy to Reference Product Stelara* in Phase III Study 16.08.2022 / 07:30 CET/CEST The issuer is solely responsible ... Seite 1
On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference...
Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements. Amidst the breathtaking sweep of activities in the Trump Administration’s waning days in office, the Orange Book Transparency Act of 2020 (the “Orange Book Act”) and the so-called Purple Book Continuing Act (the “Purple Book Act”) were both signed into law with relatively little public fanfare. Both of these bills largely codify in statute the patent-listing and related requirements currently incorporated in FDA’s regulations and guidance. Nevertheless, the recen...