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Management Forum

Biosimilars Training Course

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

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

4-5 Jul 2022 + 1 more date

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

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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

Who should attend?

The event will be relevant for those working in:

Regulatory
Quality assurance
Pharmaceutical development
R&D

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The Biosimilars course will cover:

Day 1
Day 2

Global considerations and definitions of biotech/biosimilar products

What is a biologic and legal definitions
What makes biological molecules different to small molecules?
Product equals the process – what does this mean?
What is a biosimilar – the layman versus the legal definition
Review small molecule versus biotech

Registration of biosimilars

EMA/FDA attitude towards biosimilars, safety/efficacy/quality, clinical and non-clinical evaluation, PK/PD study, immunogenicity, extrapolation, PV, prescription information
Regulatory procedures for approval in EU and US
Regulators/company perspectives on interchangeability and switching
Potential strategic impact to development for interchangeability claim

Understanding the key dossier requirements for biotech products versus pharma products – Module 3

Comparability versus similarity data
- How to decide if further clinical studies are required
- What further testing is required?
- Type and design of studies – indication studies, multiple indications, bridging studies, biomarkers, PK limits, safety
Non-clinical considerations
- How to address immunogenicity and how to use the information
Clinical considerations
Detailed review of Module 3 sections for CTD 3.2.S and 3.2.P
Understand QbD for biotech products

Review of Modules 4 and 5

EU/US examples of clinical and non-clinical developments
Key concepts of clinical comparability and totality of similarity

Analysing the regulations and impact on the following procedures

Marketing applications
Clinical trial applications
Review procedures

Developing effective strategies/understanding for review and development of biosimilar products

Similarity versus comparability

Further considerations for IP, Perceptions, Market Entry, Cost/Time, Project Management

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Marloes van der Geer

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier. Marloes’ areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).

More details

Book Biosimilars Live online training

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*

4-5 Jul 2022

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 12568

GBP 1,099 1,299
EUR 1,579 1,859
USD 1,786 2,098

Until 30 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

11-12 Oct 2022

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 11747

GBP 1,099 1,299
EUR 1,579 1,859
USD 1,786 2,098

Until 06 Sep

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

* 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.

Reviews of IPI's Biosimilars training course

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

Oct 6 2020

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