Replies to post #16385 on Momenta Pharmaceuticals, Inc. (MNTA)

[Boing x 2]

DewDiligence,

I agree.

A couple of thoughts,

I think this is critical wording to avoid the games of sales reps telling the doctors to write a script DAW {drawn as written) to keep competition away.

"57 351(k)(4) of the PHS Act, means that “the biological product may be substituted for the

58 reference product without the intervention of the health care provider who prescribed the

59 reference product.”6

"134 An interchangeable product may be substituted for the reference product without the intervention

135 of the health care provider who prescribed the reference product "


I have seen comments by sales reps doing that exact thing and joking about it on line. Keeping sales away from us by telling the doctor’s to write the script DAW so the pharmacist can’t change it.

I would get the patent to cover either way of injection. Doesn’t mean you have to do it but, it would keep others from saying well they didn’t cover auto injector. Amphastar comes to mind on an end around.


"A sponsor developing an

654 interchangeable product generally should not seek licensure for a presentation for which the

655 reference product is not licensed. For example, if the reference product is only marketed in a

656 vial and a prefilled syringe, a sponsor should not seek licensure for the proposed interchangeable

657 product for a different presentation, such as an auto-injector."


Boing X 2

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Its been a long time coming but I think this was well thought out draft guidance on interchangeability guidelines while allowing for flexibility by the FDA and also providing substantial guidance to companies.