Bioanalytical Support of Biosimilars: Expect the Unexpected, Upcoming Webinar Hosted by Xtalks

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In this complimentary webinar, Dr. Petra Struwe will discuss the direct impact of the biosimilar bioanalytical assay set-up and its impact on the statistical endpoint of the clinical trials comparing pharmacokinetic and/or pharmacodynamic (PK/PD) properties of a biosimilar drug candidate and its innovator compound.

Based on experiences gained from support of the first wave of biosimilar products to gain approval in the US and EU, Celerion will share key learnings from engagement with several biosimilar programs.

The success of early clinical studies comparing a biosimilar drug candidate with the innovator compound is highly dependant upon the quality of the bioanalytical methods and design of early PK/PD drugs as well as the product similarity. Based on experiences gained from support of the first wave of biosimilar products to gain approval in the US and EU, Celerion will share key learnings from engagement with several biosimilar programs. This includes the rationale for the one assay approach and how the two-step approach can help set up such an assay.

A two-step approach refers to a robust validation of a single assay which includes both the innovator and biosimilar demonstrating analytical similarity and comparable reactivity. Challenges include extention of the limit of precision for ligand binding assays and how adapted routine analysis best practices can be applied to overcome these issues.

Join Dr. Petra Struwe, Executive Director of Bioanalytical Services, Celerion, for the live webinar on Wednesday, December 9, 2020 at 11am EST (4pm GMT/UK).

For more information, or to register for this event, visit Bioanalytical Support of Biosimilars: Expect the Unexpected.

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Ayesha Rashid
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