In bid to lower prices, Gottlieb says FDA will take new action to speed approval of biosimilars

FDA Commissioner Scott Gottlieb on Wednesday criticized branded drug companies, distributors, and PBMs for practices that reduce competition and restrict market access to generic drugs, including biosimilars. FDA is enacting new policies to speed the testing and approval of generic drugs, which in turn, should lead to lower overall drug prices.

FDA Commissioner Scott Gottlieb on Wednesday criticized branded drug companies, distributors, and PBMs for practices that reduce competition and restrict market access to generic drugs, including biosimilars. FDA is enacting new policies to speed the testing and approval of generic drugs, which in turn, should lead to lower overall drug prices. "We can bring more competition to the market," said Gottlieb, citing as an example new initiatives to make it easier for makers of biosimilars to demonstrate that their products are equivalent to the branded biologics they seek to compete against. He noted, however, that even if more biosimilars are approved, market access is still often artificially restricted by the rebate schemes between branded biologic makers and PBMs.