PCMA issues statement on FDA biosimilar action plan

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WASHINGTON — Pharmaceutical Care Management Association (PCMA) president and chief executive officer Mark Merritreleased the following statement on the Food and Drug Administration’s (FDA) new Biosimilars Action Plan:

Mark Merritt

“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.”




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