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2017-06-29 FDA Biologics Pathway

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FDA Creates Pathway for Interchangeable Biologics

Posted: June 29, 2017


The market for biosimilars in the United States has developed tepidly with only four biosimilar products being approved by the FDA as of June. However, after the FDA released its highly anticipated, but long delayed interchangeability guidelines, the market seems primed for new developments.

While none of the biosimilars currently on the market have been designated as interchangeable, the FDA expects that there will be interchangeable designated biosimilars on the market within two years. A ranking FDA official was quoted affirming this timeline at a recent conference in Chicago. This confidence comes despite pharmaceutical companies seeking further clarification on guidelines they have deemed vague. The FDA will take these comments into consideration and has promised consultation early and often in the designation and review process.

Biosimilars that can be substituted in pharmacies represent real cost savings advantages for patients, but these concerns must always be balanced with patient safety concerns. To date, not every state has implemented legislation that requires a speedy reporting process with a patient’s physician when interchangeable biosimilar drugs are substituted. Given the new timeline laid out by the FDA, it is more important than ever that the remaining states pass legislation. To find out if your state has approved biosimilar legislation, and more on how to get involved, visit CSRO’s Advocacy Center.

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