Drug product formulation & process development needs to be risk-based and occur earlier during product development cycle of biosimilars than for originator products to ensure commercialization success. Also, the development strategy for biosimilar drug product needs to align with scientific considerations for demonstrating biosimilarity and principles of Quality by Design (QbD). QbD based approach relating to pharmaceutical development of biosimilar products will be discussed using a case-study of one of the biosimilar pipeline molecules.

Drug product development of biosimilars: QbD based approach and strategies

245th National Meeting (2013)

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