Biosimilarity is a significant issue for vaccines and a reasonable approach to this could facilitate licensing of follow-on products of similar design. However, the definitions and guideline criteria developed for similar versions of biotherapeutics may be too restrictive for vaccines, as the molecular composition of their active substances can rarely be defined precisely, and immunogenicity is an essential rather than an undesirable characteristic. Similarity in antigenic composition may be more relevant. The criteria that determine biosimilarity need more careful definition; superficial similarity may conceal significant differences in performance that can only be disclosed by careful clinical evaluation. These issues have been reviewed in detail for current types of bacterial and viral vaccines. For truly biosimilar products, limited clinical studies could be acceptable provided that they permit side-by-side comparison with the original product or another suitable reference. The prospect of the development of biosimilar products also emphasizes the need for improved regulatory tests capable of detecting subtle but biologically significant differences in vaccines. The need for an acceptable definition of biosimilarity and guidelines relevant to vaccines is emphasized.
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