On May 5, 2020, Ha Kung Wong co-authored “A Competitive Marketplace for Biosimilars” in BioPharm International. The following is an excerpt:
Interchangeability is a concept unique to the US and has caused much debate and potential confusion. FDA pointed out various examples of how statements related to interchangeability can be misleading and cause confusion for consumers in the draft guidance Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers (2). For example, in innovator materials, suggesting that a biosimilar is less safe or effective because it has not been licensed as an interchangeable would be misleading. In materials for biosimilars that are not licensed as an interchangeable, sponsors need to avoid creating the impression that they have been licensed as interchangeable.
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