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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.

11-12 Jan 2022

& 4-5 Apr 2022 , 4-5 Jul 2022 , 11-12 Oct 2022

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Details

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

Programme

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


Presenter

Marloes van der Geer (More...)

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).

Book now

Book now

11-12 Jan 2022
Face-to-face, (venue not yet confirmed)
11-12 Jan 2022
Face-to-face
(venue not yet confirmed)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 7 Dec*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
4-5 Apr 2022
Live webinar
4-5 Apr 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 28 Feb 22*
Enrol now
to attend
Live webinar
4-5 Jul 2022
Face-to-face, (venue not yet confirmed)
4-5 Jul 2022
Face-to-face
(venue not yet confirmed)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 30 May 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
11-12 Oct 2022
Live webinar
11-12 Oct 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 6 Sep 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

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

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • AS Kalceks
  • Ewopharma International, s.r.o.
  • Gilead Sciences
  • ipsen
  • Lallemand Conseil
  • Mylan Pharma GmbH
  • PharmaIT
  • PharmaLex UK Services Ltd
  • Qdossier
  • Sieć Badawcza Łukasiewicz
  • Sochinn Consulting
  • syneos health
  • UCB Biopharma
  • Zentiva Group, a.s.

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 20

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

Frédéric LALLEMAND, Consultant, Lallemand Conseil, Oct 20

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

, Zentiva Group, a.s., Oct 20