Webinar

Biosimilars – Landmark Developments Point to the Future for Regulations and Analysis

Published

Format: External webinar | Document type: Webinar

Biosimilars – Landmark Developments Point to the Future for Regulations and Analysis
2013 is a landmark year for biosimilars, with the approval of the first biosimilar mAb and regulatory developments across the globe. Correctly interpreting the analytical requirements in these regulations is critical to demonstrate Biosimilarity. This webinar will review the evolution of biosimilar regulations and their impact in the EU, US, and the rest of the world. Additionally, appropriate strategies for primary and higher order structure determination to demonstrate biosimilarity will be discussed, particularly for antibodies where their size and complexity requires LC/MS/MS approaches. 

Speakers

Fiona Greer Fiona Greer Global Director, BioPharma Services
SGS Life Science Services

Hoss Dowlat Hoss Dowlat Vice President, Regulatory Affairs, Global Strategy
PharmaBio Consulting

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