Nonclinical and Clinical Safety Assessment of Biosimilars: Status and Perspective
Thursday, July 25, 2013 |Archive Now Available
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.
Director Toxicology within Biologics Safety Assessment / Translational Sciences
MedImmune, Gaithersburg MD
Joerg Bluemel is responsible for the nonclinical safety assessment and development strategy of bio-therapeutics in various indications. Dr. Bluemel is a board certified toxicologist and has more than 15 years of experience in nonclinical safety / nonclinical drug development for small molecules and bio-therapeutics. Prior to joining MedImmune, he was the Head of Nonclinical Safety / Drug Metabolism at Merz Pharmaceuticals GmbH, Germany.
Dr. Bluemel has an academic background in immunotoxicology and received his PhD from the University of Düsseldorf, Germany.
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Date : July 25, 2013
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