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Abstract:
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Biosimilar products have received more attention recently because many innovative biological products are losing their patent protection. The biosimilar should be highly similar, not identical, to the innovative biological product from the European Medicines Agency's guidance and the U.S. Food and Drug Administration's guideline. In this research, we focus on establishing posterior criterion to assess the biosimilarity between the biosimilar product and the innovator product. More specifically, we consider the prior information of the reference product and a non-informative prior to build the mixture empirical prior information of the biosimilar product. Then, we construct a posterior criterion to check the biosimilarity between the reference product and the biosimilar product. If the posterior probability of the similarity criterion is higher or equal to a pre-specified level, the biosimilarity between the reference product and the biosimilar product will be concluded. Numerical examples illustrate applications of the proposed approach in practice.
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