4.4 Japan: PMDA The PMDA has historically required comparability studies against locally sourced reference products, which adds cost and time for biosimilar developers who have already compared against US- or EU-sourced reference products
It compresses refill logistics, shifts the missed dose problem, and could reduce the number of injection events that patients dread
If you are pregnant, nursing, taking medication, or have a medical condition, consult with a healthcare professional before using this product
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8: McGuire FP, Martinez R, Lenz A, Skinner L, Cushman DM
10.1016/J.INOCHE.2025.115195 77