The FDA released the proposed changes in September 2023.
The FDA’s recent proposed changes to its Labeling for Biosimilar and Interchangeable Biosimilar Products are set to redefine the way these products are identified and understood by the public, pharmacists, and drugmakers. Although the changes are not expected to impact consumers significantly, they mark a significant shift in the FDA’s approach to biosimilar labeling.
- The FDA no longer recommends including an interchangeability statement in the labeling for interchangeable biosimilar products.
- The public and pharmacists would need to consult the FDA’s Purple Book to identify approved biosimilar and interchangeable biosimilar products.
- The change in guidelines will impact drugmakers and the process by which applicants develop proposed labeling for biosimilar and interchangeable biosimilar products.
- Other proposed changes from the 2018 guidance include new recommendations on product identification, pediatric use statements, and incorporating relevant immunogenicity data.
- The FDA emphasized that their recommendations are nonbinding and do not have the force of law.
- The agency encourages interested stakeholders to comment on the draft guidance.
According to a report by Grand View Research, Inc., the global biosimilars market size was valued at USD 13.1 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 31.7% from 2021 to 2028.
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