The “Biosimilars” conference has been added to ResearchAndMarkets.com’s offering.
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.
The 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
Agenda
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
Further considerations
- IP
- Perceptions
- Market entry
- Cost/time
- Project management
For more information about this conference visit https://www.researchandmarkets.com/r/7unksw
View source version on businesswire.com: https://www.businesswire.com/news/home/20200304005554/en/
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