Biosimilars
Full-length
Program

Month 1 - Development of a Biosimilar Product | Focus: Biosimilar principles, reference products, totality of evidence, development planning, analytical similarity, CMC development, PK/PD, immunogenicity, and development governance.

Month 2 - CMC and Clinical Writing of a Biosimilar Dossier | Focus: CTD/eCTD structure, quality documentation, CMC writing, clinical and non-clinical summaries, biosimilarity argumentation, extrapolation, comparator bridging, and regulatory response preparation.

Month 3: Biosimilar Registration Requirements and Process | Focus: Biosimilar submission requirements, Health Canada, EMA, and FDA pathways, regulatory expectations, comparator requirements, lifecycle management, interchangeability, and submission readiness.