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


31 Mar-1 Apr 2020

& 6-7 Oct 2020

GBP 1,499 1,299 *
USD 2,099 1,787 *
EUR 2,338 2,058 *
* When you book before 28 Feb

Book now

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 cover the regulatory pathways for both the EU and US and how to develop effective strategies for developing biosmilar products. 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


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

  • IP
  • Perceptions
  • Market entry
  • Cost/time
  • Project management


Andrew Willis

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.

Book now

31 Mar-1 Apr 2020
31 Mar-1 Apr 2020 Rembrandt Hotel, London GBP 1,499.00
USD 2,099.00
EUR 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
USD 1,787.00
EUR 2,058.00
Until 28 Feb*
Enrol now
6-7 Oct 2020
6-7 Oct 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

Previous customers include...

  • Gilead Sciences
  • Mylan Pharma GmbH