Biosimilar CMC and Regulatory Challenges
June 22, 2016 - Baltimore MD USPDA
elliott@pda.org
Phone:301-656-5900
This course will review the regulatory challenges from a CMC perspective of biosimilars. Participants will gain an appreciation of why biosimilars are not treated by the regulatory authorities as bio-generics and will understand the totality of what is required in bringing biosimilars into the marketplace – what has worked and what has not.
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