Toronto, Canada (PRWEB) July 15, 2013
The development of Biosimilars has gained momentum in recent years due to upcoming patent expiry of first generation Biologics and increasing financial pressure on health care systems. Consequently, regulatory frameworks are evolving in various countries to guide a path for Biosimilar drug development, however, the complex nature of Biopharmaceuticals makes the demonstration of Biosimilarity with regard to quality, safety and efficacy extremely challenging.
Based on the specific aspects of Biosimilar drug development and registration, the development strategies differ significantly from the development of an innovator product that has to establish both the efficacy and safety independently from other products.
The webinar will review the current regulatory landscape and guidance for nonclinical and clinical development of Biosimilars with a focus on safety-related aspects and discuss the current challenges and future perspectives in this area.
A live Q&A with the audience will follow the main presentation. For more information, or to register for this event please go to http://xtalks.com/biosimilars-safety-assessment.ashx
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 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 http://www.xtalks.com
Zayeeta Dasgupta, M.Sc in Life Science and Business Ma
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