SOURCE: Xtalks

Xtalks Webinars

June 27, 2017 07:30 ET

Biosimilar Development: Lessons Learned from Early Clinical Studies, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - June 27, 2017) - During a live broadcast on Tuesday, July 18, 2017, scientists from Celerion will share key learnings gained from engagement with multiple biosimilar programs for approval in the US and EU.

The success of early clinical studies comparing a biosimilar drug candidate with the innovator compound is dependent on the similarity of the products themselves, as well as on the quality of the bioanalytical assay method and the design and conduct of early PK/PD studies.

Challenges Faced with Biosimilar Bioanalytical Assays and Sample Processing

René Wuttke, Principal Investigator, Celerion, Zürich, Switzerland will share the rationale for the one assay approach and discuss how a two-step approach can help in setting up such an assay, along with the necessary prerequisites. Establishing a robust validation of a single assay with both the innovator and biosimilar compound can show analytical similarity and confirmation of comparable reactivity. This can be an important additional indicator of similarity. Lastly, he will share the challenges of pushing the limit of precision of ligand binding assays, which is essential when processing samples from biosimilar studies, and how adapted routine analysis best practices can overcome those challenges.

Practical Considerations in the Conduct of PK/PD Similarity Assessments for Biosimilars

There is a clear advantage if a biomarker of effect exists that can be incorporated into PK/PD studies early in the clinical development of a biosimilar. Establishing similarity via PK/PD modeling can greatly reduce the size of subsequent patient studies during which the similarity of safety and efficacy is assessed. David Goblot, Principal Scientist, Protocol Design and Development, Celerion, Montreal, Canada will discuss the needed elements of study design to ensure that not only PK/PD assessments are appropriate but also that sufficient sampling occurs to ensure proper immunogenicity assessment. Practical considerations in administering sub-cutaneous doses in biosimilar assessments will be reviewed. In addition, David will cover the importance of being able to recruit and manage large cohorts of subjects to reduce variability in PK/PD similarity assessments for drugs where PK can be studied in healthy subjects. Lastly, he will discuss the value of determining the degree of overlap in PK profiles as an early indicator of whether sufficient similarity exists to warrant further clinical development of the biosimilar.

To learn more about this complimentary webinar visit: Biosimilar Development: Lessons Learned from Early Clinical Studies

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit
For information about hosting a webinar visit

Image Available:

Contact Information