Tag Archives: unique names for biosimilars

Medicare Part B Demonstration Proposal Withdrawn

A Big Win For Arthritis Foundation Advocates: FDA Proposal Would Require Unique Names for Biosimilars

Today, we celebrate our tremendous Advocates and a fantastic victory! The FDA has issued proposed guidance to require unique names for biosimilar products that have submitted applications to the FDA.

The Arthritis Foundation and our team of 125,000 advocates have advocated for distinguishable names to ensure patient safety is given the highest priority. Unlike generic medications, biosimilars are not necessarily exact copies of brand name biologics. The change will lessen confusion among prescribers, allow for transparency in notification and drug substitution, strengthen patient adverse reaction tracking and make data collection easier.

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