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FDA Expectations for Demonstrating Interchangeability
11 CEO & Executive Consultant, KC Biopharma Consulting LLC, Graham, NC, USA.
Abstract:
There is a great interest from global companies who are developing biosimilars to pursue interchangeability designation for commercialization of their products in the US. An interchangeability designation will not only allow the substitutability at the pharmacy level without the intervention of a health care provider but the first sponsor who is able to garner interchangeability designation will also receive 12 months of marketing exclusivity. This paper will highlight our current understanding of FDA expectations with regards to demonstrating interchangeability.
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