Biosimilars Community Forum for an opened professional disscussion

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Recent industry news

Descussion about recent industry news, developments, interesting novelties ...

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Statistical perspectives of biosimilar development
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Solutions to handle Missing Data

Handling of missing data issues ...

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New ways in statistical modeling

Effective research model building to handle complexity in public health studies,

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Regulatory perspectives of biosimilar development
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EU EMA

Discussion about EU EMA Regulatory requirements

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US FDA

Discussion about US FDA Regulatory requirements

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WHO

Discussion about WHO rules regarding biosimilar drug products

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Design and Analysis of Biosimilar Studies
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Assessing Biosimilarity: Issues and Recent Development

Development • Fundamental differences: Generics versus biosimilars • Regulatory requirements: EU EMA, US FDA, and WHO • Definition of biosimilarity: US BPCI Act • Scientific factors for assessing biosimilarity: Criteria for biosimilarity | Non-inferiority vs. equivalence | Multiple reference products • Development of biosimilarity index: Unified and robust approach • Concluding remarks

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Assessing Interchangeability

ssues, Designs, and Statistical methods • Concept of interchangeability: Switching | Alternating • Current issues: Produce same clinical results in any given patient • Criteria for interchangeability: Adjust for variability of reference product • Study designs: Switching designs • Statistical methods • Concluding remarks

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Analytical Similarity Assessment in Biosimilar Studies

Analytical similarity assessment • Classification of critical quality attributes (CQAs) • Tiered approach – Equivalence test for Tier 1 CQAs – Quality range approach for Tier 2 CQAs – Raw data and graphical comparison for Tier 3 CQAs US FDA’s current thinking on Tiered approach

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Professional community forum in Biosimilars

The organizers of the Annual Biosimilars Forum event series established this webforum to provide a community place for a professional discussion, where the members can share their experiences, opinions and help each other in the field of biosimilar drug develomment. Let’s join us, ask our experts in our professional topics and start to disscuss with professionals working in and for biosimilar drug development!

Hosts of the forum:
Dr. László ENDRÉNYI
Professor Emeritus of Pharmacology and Statistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists
Júlia SINGER,
Chief Scientific Officer, Accelsiors CRO Ltd.;
President, Hungarian Society for Clinical Biostatistics