TORONTO (PRWEB) March 28, 2019
In the development of biosimilars, the broad definition of the similarity concept in regulatory guidelines does not directly prescribe a path for this task. Despite this uncertainty, several manufacturers have been successful and numerous follow-on biologics are approved in the US and EU as of today. In the first part of this webinar, learn how analytical similarity is achieved in biosimilars based on recently approved products in the US. This overview is complemented with analytical examples from functional assays and glycan structure analysis to illustrate the significance of data interpretation in support of the regulatory dossier.
In the second part of this webinar, attendees will learn about the analytical development and regulatory strategies pertaining to new biological entities. The examples focus once more on the importance of understanding the data and analyzing similarity by interpreting differences within the molecular context utilizing prior knowledge.
In the third part of this webinar, common specifications for biotherapeutic products will be presented. This discussion will include common push back and observations from North American and European regulators. Further case studies will be presented to illustrate strategies used to successfully avoid common regulatory traps.
Join Thomas Linnemann, PhD, Head of Regulatory CMC Customer Solutions at Solvias in a live session on Wednesday, April 17, 2019 at 1pm EDT to explore these topics and find out why data interpretation is essential to product development.
For more information or to register for this event, visit Regulatory Strategies for the Analytical Development of New Biological Entities and Biosimilars.
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