Health and Human Services Secretary Alex Azar issued the following statement on FDA Commissioner Scott Gottlieb’s announcement of a Biosimilars Action Plan to aid the development of a market for biosimilars:

“Increased competition is one of the key strategies President Trump outlined in the American Patients First blueprint to bring down prescription drug prices. Biologics represent an increasingly common treatment option and make up 40 percent of American drug spending, competition from biosimilars is desperately needed. The challenges to building a market for biosimilars are even more complex than others in the drug space. But the FDA’s announcement demonstrates the Trump Administration is unafraid to take comprehensive action to deliver more competition, more choices, and lower prices for American patients."

Read the plan here:

https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM613761

Read Commissioner Gottlieb’s speech announcing the plan here: https://www.fda.gov/NewsEvents/Speeches/UCM613452.htm

Read the American Patients First blueprint here: https://www.hhs.gov/sites/default/files/AmericanPatientsFirst