FDA Biosimilars Plan Draws From Experience With Generics

By Maria Doukas, Christopher Betti, Kathleen Sanzo, Jacqueline Berman and Michael Abernathy ( August 20, 2018, 2:29 PM EDT) -- On May 11, 2018, President Donald Trump issued his blueprint to lower drug prices that describes the Administration's plan to reduce the price of prescription drugs by, among other actions, "[a]dvanc[ing] biosimilars and generics to boost price competition."[1] The blueprint "seek[s] to encourage innovation, while also promoting better price competition."[2] To help achieve the administration's goals, the U.S. Food and Drug Administration recently unveiled the FDA's Biosimilars Action Plan, which FDA Commissioner Scott Gottlieb called "an important piece" of the blueprint.[3][4] Noting the "anemic" competition for biosimilars with only three biosimilars currently marketed in the U.S. 11 being FDA approved at the time of the BAP release,[5] Commissioner Gottlieb stated the BAP would help the FDA achieve the goals of "mak[ing] the process for developing biosimilars more efficient" and "promoting competition and affordability across the market for biologics and biosimilar products."[6]...

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