Biosimilar Development Workshop
Recent cases in biosimilar clinical development and use will be discussed
- Critical quality attributes
- Abbreviated study programme: extrapolating indications
- Similarity testing and interchangeability
- Biobetter elements and cost-saving supplements
- Comparability to pre-change product and originator
Aims and objectivesThis workshop gives you a thorough update on recent challenges in biosimilar development. Quality, clinical and nonclinical issues will be discussed with reference to recent cases.
It will also provide you with a toolbox for improving your biosimilar development and the ability to position your product.
(from 08:30 registration)
- Defining an adequate QTPP
- Quality development as the basis for biosimilar development
- Statistical approaches
- Functional characterisation
- How much deviation from the originator is acceptable?
- In vitro characterisation
10:45 Coffee break
- Is abbreviated development permitted?
- Valid surrogates
- Equivalence or non-inferiority
- Extrapolation of therapeutic indications
- 'Totality of evidence' concept
- Clinical development in the field of oncology
- Immunogenicity and interchangeability
- EMA regulatory requirements and thinking Guideline Which assay format is valid?
- Selected examples
- Similarity testing of critical quality attributes lead to the set-up of advanced methods initially established for comparability exercises
- Regulatory view of the clinical relevance of pharmacological assays may affect granting of similarity status and extrapolation
- Rituximab biosimilars: off label phase III model "low-tumour burden follicular lymphoma" for demonstration of clinical similarity
- Demonstration of interchangeability between Cyltezo and Humira
- Infliximab biosimilar Remsima: biobetter elements on top of biosimilar status
- Infliximab biosimilar Remsima: a therapeutic drug monitoring kit as a cost-saving supplement
15:30 Coffee break
- Comparability (to pre-change product and originator)
- How to keep your product a biosimilar
17:00 End of workshop
60329 Frankfurt am Main
- Three absolute experts in biosimilars to engage with
- Current cases in biosimilar development (in the EU and US) will be discussed in detail
- All crucial development issues will be addressed
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