Outgoing US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has said the coming years will be critical for the biosimilar market, which makes generic versions of biologics. Gottlieb also noted that his successor will be tasked with managing the emergence of gene and cell therapies, as well as the use of anti-competitive tactics by pharmaceutical companies to delay generic rivals to their drugs. Most notably, Gottlieb called attention to abuse of a system known as Risk Evaluation and Mitigation Strategy, or REMs, that's used to ensure medicines are distributed and prescribed safely. The FDA is currently reviewing a proposal from Roche Pharmaceuticals Inc. (RYZ), which would allow it to sell its drug Avastin, made in partnership with GlaxoSmithKline, at lower prices than
Outgoing US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has said the coming years will be critical for the biosimilar market, which makes generic versions of biologics. Gottlieb also noted that his successor will be tasked with managing the emergence of gene and cell therapies, as well as the use of anti-competitive tactics by pharmaceutical companies to delay generic rivals to their drugs. The FDA is currently reviewing a proposal from Roche Pharmaceuticals Inc. (RYZ), which would allow it to sell its drug Avastin, made in partnership with GlaxoSmithKline, at lower prices than