Today, Premier and 9 other healthcare groups sent a letter to the FDA in response to the agency’s draft guidance on obtaining an interchangeability designation for a biosimilar drug.
In the letter, Premier expressed support of the draft guidance, but did make the argument that FDA should permit a designation of biosimilarity parallel to granting an interchangeability designation if the applicant seeks both at the time of initial approval. In addition, the letter states that any applications that demonstrate “the same clinical results as the reference product in any given patient,” as required by statute, should be deemed interchangeable.
However, the letter does disagree with the draft guidance’s requirement that applicant seeking an interchangeable designation rely on switching studies exclusively using U.S.-licensed reference product. There is no scientifically justifiable distinction between reference products acquired in the U. S. and those licensed in other comparable markets. This requirement will create significant burden on biosimilar manufacturers pursuing switching studies, who can often acquire equivalent samples of reference products from other highly regulated markets at much lower costs. Requiring switching studies to rely on more expensive, U.S.-licensed reference product samples over less costly samples from other markets, without any real clinical difference between the two will simply create additional, unnecessary barriers to entry for biosimilar developers.
To view a full copy of the letter, please visit: https://www.premierinc.com/wpdm-package/group-letter-interchangeability-52017/