Momenta Pharmaceuticals, Inc. (MNTA)

[indigokid]

After a quick review I'd say this is a positive development for MNTA. It reads very similar to what MNTA has been saying over the last several years and obviously their input on the committee consulting on writing the draft regulations was considered. Terms such as "totality of evidence" and "fingerprint like" are terms used by MNTA in both approval of Enox as well as 20mg Copaxone.

No specific requirements for human testing only a switching study play right into MNTA's strengths. Also, all the recommended studies and data sets seem like all the ones MNTA used in determining sameness in past approvals.

Its been a long time coming but I think this was well thought out draft guidance on interchangeability guidelines while allowing for flexibility by the FDA and also providing substantial guidance to companies.