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A Beginner’s Guide to Biosimilarity

This eLearning module reviews the fundamental concepts of of biologics and biosimilars. It investigates how biologics are different from chemical drugs and generics. It also looks at manufacture and evaluation of biosimilars, and their safety and efficacy comparison with the innovator drugs.

  • What are biolgics and biosimilars

  • Regulatory expectations in development of biosimilars

  • “Totality of evidence” approach to ensure complete similarity between innovator biologic drug and biosimilar

  • Biosimilar development:

    • Reference product selection

    • Analytical evaluation including structural and impurities characterization

    • Functional evaluation, Nonclinical/ toxicological evaluation

    • Clinical evaluation and pharmacovigilance

Why it matters

Biosimilar approval by regulatory bodies require a lot less clinical data when compared to innovator biological drugs. Analytical and functional assessment to establish similarity constitutes the biggest chunk of data requirement in biosimilar approvals. Understanding totality of the evidence as well as the basic research premise to establishing biosimilarity is important. This ensures that the previously proven safety and efficacy of the reference biological product also applies to the biosimilar

Who is it for

Employees working in researching and development of biosimilars\, performing analytical and functional evaluations and reviewing regulatory submissions should complete this module.

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