3 Day Masterclass in Biosimilars | Terrapinn Training
3 day Masterclass




This course extrapolates from conventional generics into the specialised area of biosimilars. By combining aspects of technology, regulatory affairs and commercial aspects, this course will provide you with a wide ranging overview of the status of the biosimilar industry.

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get the latest insight

Gain a firm understanding of the CMC, Nonclinical & Clinical regulatory requirements and expectations (FDA, EMA and WHO) for biosimilars

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expand your knowledge

Appreciate why biosimilars are not treated by the regulatory authorities as bio-generics

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get practical

Partake in a comprehensive, scientific biosimilarity exercise to understand what has worked and what has not, when bringing biosimilars to the market


Biosimilars are very much more complicated than small molecules in terms of manufacturing and testing and this leads to a level of uncertainty that results in additional requirements in terms of regulatory approvals. 

Registration processes for these products are completely different in the European Union and the USA, and price rebates are hugely different. Almost daily there are new requirements related to such simple things as how the biosimlar should be named and whether such products are substitutable or not. These changes dramatically affect the strategy companies need to adopt and this course will show how these changes relate to market situations and forward planning.

In just 3 days you will:

  • Learn how to make successful Biosimilar registration applications
  • Know how to plan, organise and submit successful Biosimilar registration applications
  • Gain practical insight into how the Regulators review your submissions
  • Get advice on how to streamline your application
  • Understand how to Implement time-saving strategies for streamlining your application
  • Examine the latest EMA vs. FDA guidelines
  • Learn about EMEA guidance on immunogenicity assessment of biotechnology derived therapeutic proteins
  • Clarify EMA guidance on immunogenicity assessment of biotechnology derived therapeutic proteins

Organisations that will benefit:

  • Biotechnology Companies
  • Innovative Pharma Companies
  • Generic Pharma Companies
  • Investors & Banks
  • Private Equity & Hedge Funds
  • Law Firms
  • Suppliers

Who will attend:

  • C-Level Executives
  • Biosimilars
  • R&D
  • Product Safety & Quality Management
  • Manufacturing Personnel
  • Project Managers
  • Product Development
  • Strategy Planning
  • Regulatory/Legal Affairs & Compliance
  • Business Development & Sales

Course Agenda

  • The Big Picture
  • Speed Networking
  • Overview of biologics
  • What differentiates biosimilars
  • The main biosimiars and their clinical use
  • Regulatory Pathways for the approval of biosimilar medicines in different countries
  • Regulatory perspectives on substitution and interchangeability
  • Addressing the paradigm shift in clinicians views
  • The effect of substitution rulings on biosimilar uptake
  • Impact of nomenclature regulatory decisions on market penetration models and ROI
  • Biosimilar companies & players
  • The dossier model
  • Biosimilar strategies
  • Innovator defence models
  • Patent defence
  • intellectual property
  • Data exclusivity
  • REMS and patent dance in US
  • Patent status of various products
  • Commercial landscape
  • Pricing and reimbursement
  • Market penetration
  • The anomalies of European reference pricing
  • What does the future hold?
  • The threat of discontinuities to strategic planning
  • Consumer and prescriber opinion
  • Wrap up

For further information please call: +44 (0)207 092 1045

  • “The depth and knowledge of my trainer was extremely impressive. In 3 days I have had, without a doubt, a masterclass on the industry. Truly world class.”

    - Gordon Dowall Potter, Past Delegate

  • “Well worth 3 days of study!”

    - Syed Hamza, Past Delegate

  • “The training was excellent! I give it a 10 and will get my trainer's support for my next challenges.”

    - Head of Partnerships & Customer Loyalty at Avis Budget, Past Delegate

  • “Extremely constructive course with a very good dynamic and passionate trainer.”

    - Managing Director at BNP Paribas, Past Delegate

  • “Impressive and cooperative trainer who wanted to make sure the delegates understood.”

    - Budgeting, Planning & Reporting Manager, Past Delegate


We can come to you too! If you have a team of six or more, why not hold a private course? Our experts come to you and the course is tailored to your requirements.

Call +44 (0)20 7092 1045 (United Kingdom)
or +65 6322 2333 (Asia Pacific)
for more details