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Training Overview

The market share of drug products manufactured by means of modern biotechnology is constantly increasing. In Germany, it is close to 25% in value. This means that there will be a major cost saving potential for the healthcare systems by introduction of Biosimilar competition. New therapeutic options are opened for treatment of severe medical conditions and it is obvious that this product category will become even more important in the future. Consequently, it is vital for generic pharmaceutical companies to consider extending their business scope from drug products with classical chemically synthetized API to Biosimilars. The training aims to create deeper understanding why biotechnological products – and as a consequence biosimilars – are a unique product category and what aspects have to be considered in R&D and Drug Regulatory Affairs.

Key Takeaways:

  • Understand the relevance of Biotech products in therapy and the market potential for Biosimilars, including the aspect of interchangeability
  • Understand the differences between Generics, “classical” Biosimilars and Monoclonal Antibodies with their increasing complexity
  • Learn about the critical steps of host cell transformation and cell bank characterisation
  • Understand the system of EU Guidelines to prove comparability of Biosimilars
  • Learn more about the Centralised Procedure to obtain Marketing Authorisations for
  • Biosimilars, including specific requirements concerning manufacturing transfers and variations
  • See examples of study design of successfully registered Biosimilars
  • Understand the GMP requirements specific to this product category

Who should attend?

  • Heads of R&D
  • Heads of Business Development
  • Heads of QC
  • Heads of QA
  • Pharmaceutical Development managers
  • Manufacturing managers
  • Stability control managers
  • QC managers
  • Drug Regulatory Affairs managers
  • Pharmacovigilance managers


Dr. Helmut Vigenschow
Dr. Helmut VigenschowSenior pharmaceutical consultant and founder of ViPharmaService

Download the Agenda

Download detailed Agenda - Biosimilars in the EU MasterClass