This training covers core concepts and regulatory frameworks for biosimilars (EMA, FDA, WHO), clinical and PK study design, case studies (trastuzumab, insulin), extrapolation and interchangeability, immunogenicity, and health-system use. Activities include comparing requirements, analysing insulin-glargine and trastuzumab cases, and compiling a local list of licensed biosimilars.
Lecturers: Prof. Arnold Vulto, Dr. Liese Barbier