Regulatory Compliance on Biosimilar & Biological

OVERALL COURSE AGENDA

Module 1 – Global Considerations and Definitions of Biotech / Biosimilar Products

• What is a biologic – legal definitions

• What makes biological molecules different to small molecules

• Product = Process – What does this mean?

• What is a Biosimilar – Layman versus Legal definitions

• Small Molecule versus Biotech

Module 2 – Registration of Biosimilars

• EMA and FDA approach to Biosimilars (S/E/Q) – CTD Expectations

• Registration Procedures in SFDA and other Regions Globally

• Interchangeability and Switching – Regulators views

Module 3 – Understanding CTD Requirements – Module 3

• CTD Module 3 for Biotech

– Drug Substance

– Drug Product

– QbD Approach for biotech

– CTD Equation for biotech

• Comparability versus Similarity

• Totality Approach

• Key Due Diligence Factors on review of third-party dossiers

Module 4 – Review of Non-clinical and Clinical Requirements

• Non-Clinical Considerations

• Clinical Considerations

• Case Examples

• Example of data requirements

Module 5 – Analysing the Regulation and Impact

• Marketing Applications

• Clinical Trials

• Review Procedures

Module 6 – Strategic Considerations

• IP

• Perceptions

• Market Entry

• Cost/Time

• Project Management

Module 7 – Due Diligence

• Review of Dossiers from third parties

• SFDA key considerations / processes for Biosimilars

• Wrap up and Questions

TRAINER 

Andrew Willis, a seasoned regulatory and development consultant with 40 years of experience, held global

leadership roles, including Vice President of Regulatory Affairs and Medical Affairs. Specializing in CNS,

oncology, urology, and pain management, he excels in crafting business and marketing strategies for complex

pharmaceutical projects. Andrew is well-versed in EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA)

for NCEs, generics, and line extensions, particularly in sterile and biotech products.

With a wealth of experience in various applications, scientific advice meetings, Clinical Trial applications, and

orphan drug submissions, Andrew also provided training for major companies and EU Member State agencies

in CMC, variations, and advanced regulatory affairs. Notably, as SVP of Quality, Regulatory, and CMC at IO

Biotech, he played a key role in overseeing pharmaceutical development for peptide molecules and ensuring

robust quality systems.

Andrewʼs current focus involves delivering comprehensive training courses in Quality By Design, Global Module

3 Requirements, global generic development, and optimizing product lifecycles. His expertise lies in lifecycle

management, creating line extensions, and developing strategies to maximize ROI.