A two-day seminar on the overview of biosimilars and how they differ from the original biological product.
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 the development of biosimilar products
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 the EU and US
- Regulators/company perspectives on interchangeability and switching
- Potential strategic impact on 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
- A 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
- Market entry
- Project management
Mr 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. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and 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 has 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 currently has a total of 28 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. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.