Regulatory Submission of Biosimilars with a Focus on Chinese Portfolios

Day 1

Session 1: Introduction to Biosimilars & The Global Regulatory Landscape

Session 2: The Biosimilar Development Pathway & CMC Strategy

Session 3: Module 3 Deep Dive – Drug Substance (S-Sections) for Biosimilars

Exercise: Comparability Protocol Review
• Case study on assessing drug substance comparability between a reference product and a biosimilar candidate.
• Focus on analytical data interpretation and identifying gaps.

Day 2

Session 4: Module 3 Deep Dive – Drug Product (P-Sections) & Pharmaceutical Development

Session 5: Focus on Chinese Biosimilars Portfolios
• Case study: SaudiVax and integrating a Chinese biosimilars portfolio

Session 6: The Review Process & Submission Strategy for MENA
• Exercise: Dossier Gap Analysis
• Practical review of a sample CTD Module 3 from a Chinese biosimilar program
• Teams will identify SFDA-specific gaps and plan remediation

Wrap-up & Q&A

Speaker Biography

Andrew Willis  is a pharmaceutical development, quality, and regulatory expert with 40 years of experience in oncology and CNS therapeutic areas, with particular expertise in peptide- and cell/gene-based therapies. He has held senior leadership positions including Chief Development and Regulatory Officer at LIfT Biosciences, Chief Technical Officer / SVP for Quality, Regulatory and CMC at IO Biotech, and Subject Matter Expert at Prothena Biosciences. In these roles, he has led global development programs for advanced biological and biotechnological products, overseeing CMC, regulatory strategy, and quality assurance.

Andrew has extensive experience with EU and US regulatory frameworks, including NDA, BLA, ANDA, MAA, IND, and IMPD procedures, as well as orphan drug applications and scientific advice meetings. His career achievements include obtaining FDA Breakthrough Therapy designation, supporting simultaneous approvals in the US and Europe, and guiding ATMPs, biosimilars, and novel biologics through late-stage development and registration.

His expertise spans product lifecycle management, regulatory strategy for generics and novel entities, and bioequivalence approaches for oral dosage forms, areas directly aligned with ICH Q12 and ICH M13A. In addition, he continuous to pharmaceutical professionals worldwide and Regulatory Agencies on regulatory and CMC topics, with a strong focus on enabling efficient development, approval, and life cycle management of medicines.