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FDA Expectations for Demonstrating Interchangeability.

07:00 EST 1st January 2018 | BioPortfolio

Summary of "FDA Expectations for Demonstrating Interchangeability."

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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Journal Details

This article was published in the following journal.

Name: Therapeutic innovation & regulatory science
ISSN: 2168-4804
Pages: 2168479018755702

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