if I am the FDA I would think I would first look at the competitors' 20 g daily dosing, .... rather than approve a competitors' daily and thrice weekly product at the same time.
I would agree with your rationale. However, one can never predict the FDA's actions - i.e. giving Amphastar - MNTA's methods for Enoxaparin.
Also - CW 3rd Q. CC - relationships that Sandoz has built with payers give us as a strong base from which to effectively launch and market our Glatopa 40 milligram product and provides us with an important first mover advantage over other potential generic competitors.
I have not seen any mention of post-marketing issues with Glatopa except for the typical, anecdotal complaints.
CW - Sandoz has successfully established a comprehensive support service hub for patients and over 7,500 patients have been treated with Glatopa since the product launched. [No mention of any major problems either here or elsewhere.]
There's no difference between the two items except the Label and dose. I believe some of the 40mg filers haven't even filed the 20mg dose unless they filed without any press releases.