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
Two experts will give you an in-depth update on your duties with regard to accepted clinical trial data, dossier submission and the post-approval processes.
13.03.2019 in Mainz
CTD Dossier and submission in Asia, the ASEAN countries and especially China discussed in detail at this seminar
14.03.2019 in Mainz
In this seminar you will get strategic know-how for the roll-out of variations and regional know-how for the submission in LATAM, GCC and Asia.
30.04.2019 in Frankfurt
Zu dieser Frühjahrstagung trifft sich die Pharma Branche. Hier erhalten Sie erste Hand-Informationen zu den geplanten Änderungen in der Arzneimittelsteuerung (GSAV).
14. - 15.03.2019 in Berlin
Kompaktlehrgang zur Entwicklung, Herstellung und Analytik von Biotech-Arzneimittel!
19. - 21.03.2019 in Mainz