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FDA commissioner outlines 3 focus areas for improving generics competition
WASHINGTON — Food and Drug Commissioner Dr. Scott Gottlieb laid out a preliminary vision of his plans to bring more generics to market at a hearing before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies on May 25. The hearing was held as part of several others that sought input from administration officials about President Donald Trump’s proposed budget.
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FDA panel recommends approval of Hospira’s Epogen biosimilar
NEW YORK — Pfizer on Thursday announced the Food and Drug Administration Oncologic Drugs Advisory Committee recommended approval of the company’s proposed Epogen and Procrit (epoetin alfa) biosimilar across all indications. According to Pfizer, this marks the first time a biosimilar erythropoiesis-stimulating agent has been recommended for approval by a U.S. FDA Advisory Committee.