PCMA Statement on FDA Biosimilars Action Plan

WASHINGTON, July 18, 2018 /PRNewswire-USNewswire/ -- Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt released the following statement on the Food and Drug Administration's (FDA) new Biosimilars Action Plan:

"We applaud the FDA for taking important steps toward approving more biosimilars in the United States.

We are encouraged the FDA has designed a system that allows manufacturers to use comparator products not approved in the U.S. for biosimilar development. Another positive development is addressing drug manufacturer tactics used to block biosimilars from entering the market.

In finalizing guidance the FDA should promote an interchangeability policy that will allow for greater patient access to these important drugs. Increasing competition through the approval of biosimilar, brand and generic drug competitors is the key to lowering prescription drug costs for consumers, employers, and public programs."       

PCMA is the national association representing America's pharmacy benefit managers (PBMs). PBMs administer prescription drug plans for more than 266 million Americans who have health insurance from a variety of sponsors including: commercial health plans, self-insured employer plans, union plans, Medicare Part D plans, the Federal Employees Health Benefits Program (FEHBP), state government employee plans, Medicaid plans, and others.

SOURCE Pharmaceutical Care Management Association