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A Practical Guide to Biosimilar Development Strategies

4-week online academy | 2 hours per week

7 May - 4 June 2019

Online Academy

The biosimilar market is increasingly gaining prominence due to the loss of big-branded patent exclusivity and for their potential to reduce the cost of life changing medicines; making healthcare more accessible to the patient population.

However, biosimilars are difficult to verify and are governed by stringent regulatory structures which are continuously evolving. This combined with the complex manufacturing process hinders the development of biosimilars, making it more important than ever to ensure you are compliant with the current regulatory procedures to benefit from this rapidly growing market.

This course will provide you with a comprehensive insight into biosimilar manufacturing so that you are equipped with a baseline understanding of what biosimilars are. Accompanied by a detailed oversight of the biosimilar market, you will analyse regulatory challenges and procedures, current trends and future predictions.

  • Develop your understanding of what biosimilars are and how they are defined by Regulators
  • Understand the challenges of biosimilar development through a series of case studies
  • Navigate through the complex regulatory landscape for biosimilars and familiarise yourself with the most recent developments
  • Learn how to effectively position your biosimilar on the market to gain quick market access
  • Gain first-hand insight into the latest trends within the biosimilar market
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Andrew Willis

Andrew Willis has over 28 years of experience in regulatory affairs and pharmaceutical development with specific knowledge in EU and US registrations, CMC regulatory requirements and multiple clinical aspects related to successful registration of drug products.

Previously Vice President of Regulatory Affairs and Consulting Services at Catalent Pharma Solutions, Andrew now works as an independent Regulatory Affairs and Pharmaceutical Development Consultant.

This course would benefit professionals new to biosimilar development, or those who need an updated understanding of the regulatory landscape. Personnel in the following areas will find this course particularly useful:

  • Regulatory Affairs and Compliance
  • R&D
  • Quality
  • Manufacturing
  • Product Development
  • Business Development
  • Project Managers

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning. 


Over 4 weeks students will learn through:

  • 4 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisit the content with unlimited access to all the materials for 2 months
  • Access the discussion forum to interact with other students
  • Direct contact with the trainer through the forum during the 4 weeks the course is running
  • Additional content such as materials and white papers available to download

Watch the Online Academy Video

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