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 Biologics and Biosimilars

• Definitions of biologics
• Definitions of biosimilars
• Biosimilars vs generics
• The complexity of biological products
• Why “the process is the product” matters
• Exercise example from slides (“creating a copy with limited tools”)

Overview of the (e)CTD and ICH Framework

• Introduction to the (e)CTD
• Overview of ICH and its role in harmonisation
• Why the CMC section differs for biologics vs small molecules

Regulatory Pathways for Biosimilars (EMA, FDA, WHO)

• Review of biosimilar guidelines
• Stepwise approach to evidence generation
• Quality, non-clinical, and clinical evidence requirements
• Global similarities and differences

Session 2 | Day 2

210 mins | 1:00 PM

Module 3 for Biosimilars — Section by Section

• Breakdown of Module 3 sections
• Biosimilar-specific expectations noted in slides
• Key challenges for sponsors (global development, uncertainty, cost)

Additional Regulatory Topics

• Interchangeability
• Naming
• Labelling
• Pharmacovigilance
• Non-comparable biologics

Strategic Considerations for Biosimilar Development

• Global development considerations
• Cost challenges
• Market uncertainty
• Current biosimilar landscape and major players
• Summary of key points to consider

Case Study

• Analysis based entirely on the slides
• Group review and discussion

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.