| Conferences \ BioProcessing, Biologics & Biotherapeutics Congress \ Antibody and Peptide Therapeutics \ Agenda \ William Egan |
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Biosimilars and the US-legislation: Analytical and Clinical ChallengesThursday, 21 July 2011 at 14:15  Add to Calendar ▼2011-07-21 14:15:002011-07-21 15:15:00Europe/LondonBiosimilars and the US-legislation: Analytical and Clinical ChallengesSELECTBIOenquiries@selectbiosciences.comRecent legislation in the US provides a path forward for the licensure of biosimilar proteins; this legislation also allows for the interchangeability of the biosimilar with its reference product. This talk will emphasize some of the analytical and clinical challenges in demonstrating the “highly similar” nature of the biosimilar candidate and reference product, particularly for more complex proteins, such as the monoclonal antibodies. |
Add to Calendar ▼2011-07-20 00:00:002011-07-21 00:00:00Europe/LondonAntibody and Peptide TherapeuticsSELECTBIOenquiries@selectbiosciences.com
