Development of a Biosimilar Product

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 scientific principles of biosimilar development.

• Define the key stages of a biosimilar development program.

• Select and justify the reference product strategy.

• Identify and assess critical quality attributes.

• Understand the role of analytical similarity in reducing clinical uncertainty.

• Link CMC, non-clinical, clinical, and regulatory requirements.

• Identify major development risks and mitigation strategies.

Weekly Topics

Week 1: Biosimilar Development Principles

• Definition and concept of a biosimilar product

• Difference between biosimilars, generics, and innovative biologics

• Totality of evidence approach

• Reference product selection

• Local versus foreign-sourced reference product

• Quality Target Product Profile

• Residual uncertainty concept

• Early development planning

Week 2: CMC Development and Analytical Similarity

• Cell line development

• Upstream and downstream process development

• Formulation development

• Device or presentation considerations, where applicable

• Critical Quality Attributes

       - Primary structure

       - Higher-order structure

       - Purity and impurities

       - Aggregates

       - Charge variants

       - Glycosylation

       - Potency

       - Functional activity

• Analytical similarity strategy

• Forced degradation and stability studies

• Control strategy development

Week 3: Non-Clinical and Clinical Development Strategy

• Role of non-clinical studies in biosimilar development

• When animal studies may be reduced or waived

• PK/PD study design

• Selection of sensitive population

• Comparative clinical efficacy study considerations

• Immunogenicity assessment

• Safety evaluation

• Extrapolation of indications

• Comparator bridging strategy

Week 4: Development Governance and Risk Management

• Integrated biosimilar development plan

• Development milestones and decision gates

• Cross-functional governance

• Role of CMC, clinical, regulatory, QA, IP, and commercial teams

• Development risk register

• Common biosimilar development red flags

• Readiness for regulatory submission

• Transition from development to dossier preparation

Assessment

• Quiz and Q&A