11^th European Biosimilars Congress

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 twelve months of marketing exclusivity. This presentation will highlight our current understanding of FDA expectations with regards to demonstrating interchangeability.