Q. I.14. Can an applicant obtain a determination of interchangeability between its proposed product and the reference product in an original 351(k) application? A. I.14. (Proposed Answer): Yes. Under the BPCI Act, FDA can make a determination of interchangeability in a 351(k) application or any supplement to a 351(k) application. An interchangeable product must be shown to be biosimilar to the reference product and meet the other standards described in section 351(k)(4) of the PHS Act. At this time, it would be difficult as a scientific matter for a prospective biosimilar applicant to establish interchangeability in an original 351(k) application given the statutory standard for interchangeability and the sequential nature of that assessment. FDA is continuing to consider the type of information sufficient to enable FDA to determine that a biological product is interchangeable with the reference product.
This should say, "FDA and MNTA (alone) are continuing to consider the type of information sufficient to enable FDA to determine that a biological product is interchangeable with the reference product. Let's see what MNTA invents."
Agree with your take on this. I would have expected that MNTA would get some lift out of this news as it validates their position that these drugs can be characterized to the point that they are treated as substitutable.