Monoclonal Antibody Biosimilars

Monoclonal antibody (mAb) biosimilars are an important segment of the biosimilars market, offering more affordable alternatives to reference mAb therapies. Developing biosimilars for mAbs presents unique challenges due to their complex structures and intricate manufacturing processes. Extensive analytical characterization, including physicochemical and functional assessments, is crucial to establish similarity to the reference mAb. Comparative clinical studies are conducted to demonstrate similar efficacy, safety, and immunogenicity profiles. Regulatory agencies have specific guidelines for the development and approval of mAb biosimilars, ensuring a comprehensive evaluation of quality attributes. The availability of mAb biosimilars expands treatment options for patients, increases competition, and potentially reduces healthcare costs, while maintaining high standards of safety and effectiveness.

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