Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Date: Wed 11 July 2018 at 16:00 BST / 08:00 PDT
The US FDA defines a biosimilar as a biological “product highly similar to the reference product without clinically meaningful differences in safety, purity and potency.” In other words, a biosimilar is a copy of an approved version of a biologic drug. There is an increased interest in developing biosimilars for the US and Global markets since many of the first generation biologics’ patents are expiring.
Views about how to approach the development of PK, ADA and NAb assays for biosimilars vary, but what’s the best way? This webinar will explore the different options and focus on the clinical bioanalytical scientific and regulatory aspects of biosimilar drug development. The regulatory aspects, including case studies, will also be discussed.
You will learn:
Our Expert: Valentine Barra, Associate Director, Bioanalysis, Intertek Pharmaceutical Services
Please complete the form below to register.