ACR applauds legislative and regulatory initiatives to expedite approval of new biosimilar therapies

Aug 26 2017

"Expanding our patients' access to safe, effective, and affordable biologic and biosimilar therapies is a top priority of the rheumatology community. Therefore, the American College of Rheumatology applauds new legislative and regulatory developments that will expedite the approval of new therapies, increase competition, and lower the cost of these drugs.

The American College of Rheumatology applauds the enactment of the FDA Reauthorization Act of 2017, which was signed into law on August 18. The bill, which passed both chambers of Congress with overwhelming bipartisan support, reauthorizes the U.S. Food and Drug Administration's user fee agreements for prescription drugs, generic drugs, medical devices, and biosimilars for an additional five years. The funds generated from the user fee program are critical to the FDA's efforts to bring new biosimilar therapies to market as quickly and safely as possible, so we are encouraged to see Congress working in a bipartisan fashion to renew this important program.

Separately, we applaud FDA Commissioner Scott Gottlieb for spearheading a new hiring initiative – in line with the principles outlined in the 21^st Century Cures Act – that allows the FDA to onboard experts in the regulation and approval of biosimilars. These innovative hiring practices will fulfill the agency's goal of optimizing drug approvals to increase competition, lower costs, and improve patient access to safe and proven biosimilar therapies.

The rheumatology community looks forward to continued engagement with Congressional leaders and the FDA as we work toward the goal of bringing safe, effective, and affordable biosimilar therapies to all Americans who need them."