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Starts 18 May 2020
Online Academy,
4 module series over 4 weeks

A Practical Guide to Biosimilar Development Strategies

Discover how to effectively position your biosimilar on the market and maintain compliance on this 4-week online academy

In light of recent developments

If you would like to start the course sooner than advertised please contact us and we will arrange this for you as soon as possible.

Course Overview

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

Biosimilars are difficult to verify though 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.

What will you learn?

Key definitions

Develop your understanding of what biosimilars are and how they are defined by Regulators

Challenges to biosimilar development

Understand the challenges of biosimilar development through a series of case studies

Regulatory requirements

Navigate through the complex regulatory landscape for biosimilars and familiarise yourself with the most recent developments

Market access

Learn how to effectively position your biosimilar on the market to gain quick market access

Latest trends

Gain an insight into the latest trends affecting the biosimilar market

Who is this course for?

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

Find out more about online courses...

BioProcess International Academy online courses are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.


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applied content during the course to their role
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