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.
Global Director, BioPharma Services
SGS Life Science Services
Vice President, Regulatory Affairs, Global Strategy