Amid a flurry of newly-published guidelines on biosimilars and biologic drugs, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has set out his vision for the future of the US biosimilars market.
FDA’s Gottlieb Rolls Out A Raft Of Biosimilar Reforms
As the FDA publishes several key guidance documents on biosimilars and biologics, Commissioner Scott Gottlieb has outlined the latest steps in the agency’s ongoing efforts to support the market. These include measures to address the abuse of REMS, as well as transitioning products such as insulin and human growth hormone into the biologics framework.
