Bioequivalence and Bioavailability Forum

Hello Prasanth,

❝ We are working on Desmopressin molecule for EU submission. There are two reference products available in EU as per the SPC for Desmopressin with two different indications as follows:

❝

❝ - DDAVP Melt 60 mcg, 120 mcg and 240 mcg oral lyophilisate of Ferring Pharmaceuticals Ltd indicated for the treatment of vasopressin-sensitive cranial diabetes insipidus or in the treatment of post-hypophysectomy polyuria/polydipsia.

❝

❝ - DesmoMelt 120 mcg and 240 mcg oral lyophilisate of Ferring Pharmaceuticals Ltd indicated for the treatment of primary nocturnal enuresis.

Very interesting portofolio situation. A US-inspired portfolio strategy?

❝ Now my question is, can we perform one bioequivalence study with higher strength i.e. 240 mcg with reference product DDAVP Melt oral lyophilisate and get marketing authorisation holder for both the indications as the active substance is same in both the reference products.

Wow, this is an interesting situation and I have a feeling this can be viewed from two completely different angles.
I skimmed through the PAR (click here) and the SPC's, and it is my impression that the two reference products at 120 mcg and 240 mcg are identical, in the sense of two identical products having different indications.
I do not think there is any clear regulation that deals with this situation, but I believe it should be argued that one BE study should suffice for both indication. I would certainly recommend a scientific advice for this purpose (and you should remember to play the ethics card), it all comes down to the interpretation of terms like "the reference product", "generic" which are used in article 10.1/10.2.

Try and imagine the different scenarios that could lead to the similar situations.

You might face opposition (+lawsuits?) on the grounds that the two Ferring products DesmoMelt and DDAVP Melt may be considered two different products (different MA numbers etc) in the sense that they do not constitute one and the same reference product. Which way it goes for you will be interesting to hear. Is anyone aware of some cases that form precedence?