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Biosimilars In-house Training

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)"

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Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course overview

Prepare for the biosimilar market growth as some of the world’s best-known biologics face patent expiration in the coming years.

In today's pharmaceutical landscape, the rise of biosimilars presents a pivotal shift in therapeutic options, offering more affordable alternatives to biologics whose patents are expiring. With major biologics facing patent expiration in the near future, the biosimilars market is poised for substantial growth, driving increased interest and investment in this sector.

This seminar delves into the critical distinctions between biosimilars and their reference biologics, addressing the complex regulatory pathways and challenges in both the EU and US markets.

Participants will gain insights into essential dossier requirements specific to biotech products compared to pharma products, alongside strategies for successful biosimilar development. Moreover, the course emphasises key biological considerations and the concept of totality in biological reviews, discussing unique aspects of biosimilars compared to small molecule generics.

This course will equip attendees with comprehensive knowledge essential for navigating the evolving biosimilar landscape.

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.

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

Who should attend?

This course is perfect for pharmaceutical professionals working in regulation, quality assurance, pharmaceutical development, and R&D, including:

Regulatory affairs professionals
Medical affairs professionals
Clinical development managers
Quality assurance personnel
Legal and compliance officers

This course will cover:

Day 1
Day 2

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

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

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 Israel
QP Trainee, Unipharm Limited

Mar 5 2024

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

Ainars Gavarans Latvia
Olainfarm AS

Jul 12 2023

It felt comprehensive. An excellent resource going forward.

James McCracken United Kingdom
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 Italy
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 United Kingdom
Regulatory Affairs Officer, Thornton and Ross Ltd

Oct 6 2020

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

Czech Republic
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 United Kingdom
Manager, Regulatory Affairs, PharmaLex UK Services Ltd

Oct 6 2020

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

Frédéric LALLEMAND France
Consultant, Lallemand Conseil