CMC & Clinical Writing of A Biosimilar Dossier

Duration: 4 weeks (Course: 8 hours, Assessment: 2 hours)

Can be taken individually: Yes

Learning Objectives

By the end of the course, learners will be able to:

• Understand the biosimilar regulatory pathway in Canada, the EU, and the US.

• Compare Health Canada, EMA, and FDA expectations.

• Identify reference product and comparator requirements.

• Understand the role of scientific advice and regulatory meetings.

• Define the expected quality, non-clinical, and clinical data packages.

• Understand labeling and indication extrapolation expectations.

• Identify key submission risks.

• Prepare a jurisdiction-specific registration strategy.

Weekly Topics

Week 1: Biosimilar Dossier and Concept

• Definition of biosimilar vs. generics and innovative biologics

• Key biosimilar terminology

• Reference product and comparator requirements

• Role of analytical, functional, non-clinical, and clinical evidence

• Clinical evidence expectations, including PK/PD, safety, efficacy, and immunogenicity

• Extrapolation of indications and comparator bridging requirements

• CTD/eCTD structure of the biosimilar dossier

• Common terminology and dossier-writing mistakes to avoid

Week 2: Health Canada Biosimilar Registration Process

• Health Canada biosimilar pathway

• New Drug Submission requirements for biosimilars

• Canadian reference biologic drug requirements

• Use of non-Canadian reference products

• Comparator bridging expectations

• Quality data expectations

• Non-clinical data expectations

• Clinical data expectations

• Product Monograph requirements

• Notice of Compliance process

• Post-approval changes and lifecycle management

Week 3: EMA Biosimilar Registration Process

• Centralized procedure for biosimilars

• EMA scientific advice

• Reference medicinal product requirements

• Comparability exercise

• Quality comparability expectations

• Non-clinical requirements

• Clinical requirements

• Product-class-specific biosimilar guidelines

• Extrapolation of indications

• Risk Management Plan requirements

• European Public Assessment Report considerations

Week 4: US FDA Biosimilar Registration Process

• US FDA 351(k) biosimilar pathway

• US-licensed reference product requirements

• Comparative analytical assessment

• Clinical pharmacology expectations

• PK/PD requirements

• Immunogenicity requirements

• Interchangeability considerations

• Purple Book relevance

• Patent dance considerations

• Labeling expectations

• Post-approval supplements and lifecycle management

Assessment

• Quiz and Q&A