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 . The problem is present in markets for both small molecule drugs as well as a biologics, and Gottlieb said the FDA is looking into allowing biosimilar applicants to source products from overseas as a potential workaround. Gottlieb also said that his successor will be tasked with managing the emergence of gene and cell therapies , as well as the development of anti - competitive strategies by pharmaceutical companies to delay generic rivals to their drugs . Gottlieb oversaw the FDA 's first approval of a gene therapy with Spark Therapeutics ' approval , as well as two cell therapies for cancer .
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 said that his successor will be tasked with managing the emergence of gene and cell therapies , as well as the development of anti - competitive strategies by pharmaceutical companies to delay generic rivals to their drugs . Gottlieb oversaw the FDA 's first approval of a gene therapy with Spark Therapeutics ' approval , as well as two cell therapies for cancer .