FDA Commissioner Gottieb announced the release of the Biosimilars Action Plan (BAP) to provide information about the key actions the agency is taking to encourage innovation and stimulate the “anemic” competition among biologics and the development of biosimilars. The plan includes: ● improving the efficiency of the biosimilar approval process ● maximizing scientific and regulatory clarity ● developing effective communications, and ● supporting market competition by reducing attempts to unfairly delay competition. “Biologics represent 70% of the growth in drug spending from 2010 to 2015…. While the FDA has approved 11 biosimilars through 2018, only three are now marketed in the U.S,” Gottlieb states.
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