PCMA Statement on the FDA Advisory Committee’s Vote to Approve the First U.S. Biosimilar

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Increased Competition Lowers Drug Costs

Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt issued the following statement on yesterday’s Food and Drug Administration (FDA) advisory panel’s unanimous recommendation to approve the first biosimilar drug in the United States. The FDA panel concluded by a vote of 14-0 that EP2006, or Zarxio, is “highly similar” to Neupogen.

“We’re encouraged by the advisory committee’s recommendation for the FDA to approve the first biosimilar drug in the United States. Biologic drugs offer patients hope in the fight against chronic conditions like cancer and multiple sclerosis. However, these drugs have come with a very high price tag.

“This is a positive step toward increasing competition and in turn lowering prescription drug costs for consumers, employers, government programs, and others.

“To encourage use of biosimilars, the FDA should act to allow interchangeable biosimilars to be substitutable for their reference products.”

A recent white paper, “Considerations of the FDA’s Impact on Competition in the Drug Industry,” from Matrix Global Advisors released by PCMA also outlined a number of steps the FDA can take to increase competition in the pharmaceutical marketplace to lower prescription drug costs.

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