ABC Company recently completed a multicenter, randomized, placebo-controlled, double blinded phase IIb clinical study to evaluate the

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ABC Company recently completed a multicenter, randomized, placebo-controlled, double blinded phase IIb clinical study to evaluate the safety and efficacy of one of its investigational drug product (XYZ Drug) in subjects with a rare disease. After reviewing preliminary safety and efficacy data from the phase IIb study, the decision was made to conduct a multinational phase III confirmatory clinical trial to support the marketing authorization application for XYZ Drug product.

1.Discuss the importance of conducting different clinical trials phases in the development of medicinal product for human use, and elaborate on the clinical development of biosimilar medicinal products as compared to that of innovative (or reference) medicinal products.