Course Information

• The course begins at the time stated below
• The course is broken up into modules outlined below
• There will be breaks between modules

21 & 22 April 2026 | 27 & 28 October 2026

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

Session 1 | Day 1

210 mins | 1:00 PM

Introduction to Biosimilars

• What biosimilars are and how they are defined
• Key differences between biologics, biosimilars, and generics
• Understanding the inherent complexity of biological products
• Why “the process is the product” and its impact on biosimilar development

Global Regulatory Frameworks

• Overview of global regulatory pathways for biosimilars
• Roles of major regulatory authorities including EMA and FDA
• The stepwise approach to biosimilar development
  • Quality
  • Non-clinical
  • Clinical

Analytical Similarity and Quality by Design (QbD)

• Principles of analytical comparability for biosimilars
• Identification and justification of Critical Quality Attributes (CQAs)
• Applying Quality by Design (QbD) concepts to biosimilar development
• Establishing acceptable ranges and understanding variability
• Demonstrating similarity rather than identicality

Statistical Data Analysis

• Statistical considerations in biosimilar development
• Role of statistical analysis in assessing similarity
• Interpretation of comparative analytical data

Non-Clinical Studies

• Types of non-clinical studies used in biosimilar development
• When non-clinical studies are required
• Purpose and regulatory expectations

Session 2 | Day 2

210 mins | 1:00 PM

Clinical Pharmacology

• Role of clinical pharmacology in biosimilar development
• Pharmacokinetic (PK) and pharmacodynamic (PD) considerations

Clinical Immunology

• Immunogenicity assessment principles
• Evaluation of immune responses in biosimilar development

Comparative Efficacy Studies

• Requirements for comparative clinical efficacy studies
• Positioning efficacy studies within the biosimilarity framework

Manufacturing Considerations

• Manufacturing challenges specific to biosimilars
• Process development and control strategies
• Impact of manufacturing changes on biosimilarity

New Approaches to Biosimilar Development

• Emerging trends and evolving development approaches
• Alternative or modernised development strategies
• Strategic considerations for future biosimilar programmes

Case Studies and Lessons Learned

• Review of selected EMA/FDA biosimilar approvals
• Examples of deficiencies and regulatory challenges
• Participant discussion & Q&A

Conclusion

• Wrap and summary of the course
• Questions and answer session

Mylène Talabardon – With over 20 years of experience in the pharmaceutical industry, Mylène has strong experience in process development, technology transfer and process validation. She obtained her PhD in biotechnology from The Ohio State University and her environmental engineering degree from the Swiss Federal Institute of Technology (EPFL). In 2001, she joined BiogenIdec in cell culture process department, focusing on antibody production from the lab scale to manufacturing scale. In 2004, she was appointed head of the cell culture department at Merck Serono and started working in validation according to QbD for biotechnological products. After 2 years as CMC lead for a biosimilar product, she was nominated Process Validation Expert, and in this position, she developed the Global Process Validation strategy for the company according to European and FDA regulations for pharmaceuticals and supported CMC teams in developing Process Validation plans for new biologics as well as for legacy products.

Hervé Broly – Starting with an engineering degree in agriculture, followed by a PhD in plant physiology,  Hervé joined the Blood Transfusion Center (Lille, France) in 1982 where he implemented a unit for the development and manufacture of monoclonal antibodies against blood groups, blood proteins and viral antigens. In 1991, Hervé took the position of Head of Process Development and Manufacturing at Sorebio (Martillac, France), a contract manufacturing organization specialized in the development and manufacture of monoclonal antibodies for clinical development. He took the lead of that company in 1998 after it was bought by Serono, a Swiss biotech company (Geneva, Switzerland) in 1994.

In 2003, Hervé moved to Serono in Geneva as Global Product Team Leader in charge of managing the development of a recombinant Ig-fusion protein for the treatment of autoimmune diseases, moving that product from Phase I to Phase III.

As of November 2006, Hervé has been appointed Vice-President, Head of Biotech Process Sciences at Merck-Serono, based in Vevey, Switzerland, in charge of developing and validating the manufacturing processes for biotechnological products. In that context, whereas Serono was mainly using perfusion processes for recombinant hormones and cytokines, we moved the company to large-scale manufacture of monoclonal antibodies using proprietary chemically-defined cell culture media and feeds. After our participation to the FDA’s pilot program on Quality by Design, the concepts described in ICH Q8(R2) and ICH Q11 were implemented in our approach to gain process understanding. It was concluded by issuing a modernized approach for process validation at Merck (Darmstadt, Germany). More recently, we have introduced advanced processes such as intensified fed-batch and continuous downstream processing.