Nonclinical and Clinical Safety Assessment of Biosimilars: Part 2 – Regulatory Perspective

This webinar will focus on EMA and FDA regulatory perspectives on nonclinical and clinical safety assessment in biosimilars.

Regulatory frameworks are evolving many countries to guide a path for biosimilar drug development, however the complex nature of biopharmaceuticals makes the demonstration of biosimilarity with regards to quality, safety and efficacy extremely challenging. Based on the specific aspects of biosimilar drug development and registration, 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:

• EMA guidelines on Biosimilar mAbs
• EMA vs. FDA regulation including a discussion of WHO guidance
• Current global regulatory environment
• Case studies and ongoing challenges

Speaker

Joerg Bluemel, 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 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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