Nonclinical and Clinical Safety Assessment of Biosimilars Webinar

July 17, 2013 8:50 AM

Xtalks presents an interactive live webinar on Thursday, July 25, 2013 at 11:00am EDT with keynote speaker Joerg Bluemel, Director of Toxicology within Biologics Safety Assessment / Translational Sciences at MedImmune.

Dr. Bluemel will discuss the current status of nonclinical and clinical safety assessment of Biosimilars.

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.

For more information about this event or to register, visit: http://xtalks.com/biosimilars-safety-assessment.ashx

 

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