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Biosimilars Training Course

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

★★★★★ "Content was informative, I've learned many new details and subjects to consider. Speaker was fluent ... more (8)"

10-11 July 2024
+ 1-2 October 2024 »

from £1099

Need help?  Enrol or reserve

Course overview

With some of the world’s best-known biologics continuing to face patent expiration in the coming years, the biosimilar market is set for continued growth.

This seminar will provide you with a global overview of biosimilars and how they differ from the original biological product. The programme will discuss the unique considerations of biosimilars as compared with small molecule generics.

Our expert trainer will cover the regulatory pathways and challenges for both the EU and US for biosimilars, and explore the key dossier requirements for biotech products compared to pharma products. Strategies for development of biosimilar products will also be discussed and you will be introduced to key biological requirements and the concept of totality for biological review.

Benefits of attending:

  • Discuss global considerations and definitions of biotech/biosimilar products
  • Gain an invaluable overview of the regulatory pathways for biosimilars in the EU and US
  • Understand the key Module 3 dossier requirements for biotech products versus pharmaceutical products
  • Learn how to develop effective strategies for development of biosimilar products

This course is part of our Biopharma training courses series which aims to provide up-to-date knowledge on industry best practices and regulations surrounding biopharmaceuticals.

Who should attend?

The event will be relevant for those working in:

  • Regulatory
  • Quality assurance
  • Pharmaceutical development
  • R&D

Enrol or reserve

The Biosimilars course will cover:

Biologics Introduction

  • Technical and legal definitions
  • Examples of biologics
  • The complexity of biologicals
  • The challenges with development of biologics

Biosimilars vs Generics

  • How the process is the product
  • A simple excursive to be reminded of the difference between biosimilars and generics
  • Creating a copy with limited and imperfect tools

The (e)CTD

  • International council of harmonization (ICH)
  • The common technical document
  • CMC explained (incl. quality by design, specifications)
  • Why the CMC section for biologics is more extensive (as compared to small molecules)

The (e)CTD Continued

The Registration Process

  • A review of EMA and FDA biosimilar guidelines
  • Biosimilar development as a step-wise approach
    • Quality
    • Non-clinical
    • Clinical
  • Non-comparable biologics
  • Other regulatory topics
    • Interchangeability
    • Naming
    • Labelling
    • Pharmacovigilance

Module 3 for Biosimilars - Section by Section

  • In-depth review of module 3 documentation with special remarks regarding biologics and biosimilars specifically

Challenges for Biosimilar Sponsors

  • Global development
  • Costs
  • Uncertainty

Main players in the Biosimilar Field

  • A review of the current situation

Strategic Considerations

  • A summary of key points to consider when (starting to) develop biosimilars

Case Study

Enrol or reserve

Andrew Willis
San Salvatore Training Ltd

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

10-11 July 2024

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 13775

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 05 Jun

View basket 

Not ready to book yet?

for 7 days, no obligation

1-2 October 2024

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 13932

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 27 Aug

View basket 

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Biosimilars training course

Content was informative, I've learned many new details and subjects to consider. Speaker was fluent and interactive. I'll recommend this course to new QP's in the future.

Mar 5 2024

Lian Abu-Obed
QP Trainee, Unipharm Limited

Mar 5 2024

I wanted to get short insight into biosimilar development process and I completely accomplished it.

Ainars Gavarans
Olainfarm AS

Jul 12 2023

It felt comprehensive. An excellent resource going forward.

James McCracken
Quality Audit Manager , Advanz Pharma

Jul 12 2023

Webinar was good, informative and lots of information. Speakers are well knowledgeable about Biosimilar Industry.

Srikanth Varma Kc
Global Audit and Due Diligence QA Manager, Abbott

Jul 4 2022

Overall I found this course really helpful and informative. One of the most enjoyable and informative seminars I have ever attended. Thank you for organizing and a very special thanks to the great speaker!

Deepthi Vanavasam
Regulatory Affairs Officer, Thornton and Ross Ltd

Oct 6 2020

Fully satisfied; even this was managed online, it was great.

Zentiva Group, a.s.

Oct 6 2020

I gained much more understanding than what I had intended to. The trainer also involved everybody in the course and did not make it boring. The topics of non-clinical, clinical, strategy as well as market entry/IP etc were covered briefly too. So that was an added advantage.

Anjali Apte
Manager, Regulatory Affairs, PharmaLex UK Services Ltd

Oct 6 2020

Globally good presentation, speaker tried to make people participate which is difficult by webinar.

Consultant, Lallemand Conseil

United Kingdom

  • Advanz Pharma
  • Advanz Pharma Services (UK) Limited
  • Gilead Sciences
  • Gilead Sciences Ltd.
  • ipsen
  • PharmaLex UK Services
  • PharmaLex UK Services Ltd
  • Phibro Animal Health
  • Subiaco Associates Ltd
  • Thornton and Ross Ltd


  • Celonic
  • ExcellGene
  • Mylan Pharma GmbH
  • Sochinn Consulting


  • unipharm
  • Unipharm Limited
  • Unipharm Ltd


  • AS Kalceks
  • JSC Olainfarm
  • Olainfarm AS


  • Abbott
  • Abbott Healthcare Products B.V
  • Qdossier


  • Novo Nordisk A/S
  • PharmaIT


  • Lallemand Conseil
  • syneos health


  • UCB Biopharma

Czech Republic

  • Zentiva Group, a.s.


  • Boehringer Ingelheim Vetmedica GmbH


  • Pharmathen SA


  • Abbott


  • Sieć Badawcza Łukasiewicz

Slovak Republic

  • Ewopharma International, s.r.o.

United States of America

  • Biogen

Enrol or reserve

Run Biosimilars Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online


We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749