505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2021-01-21 14:37 (191 d 12:02 ago) – Posting: # 22187
Views: 717

Hi Brus,

» We are developing a generic of an RLD with two strengths (100 mg and 50 mg).
»
» But viewing the dosage regimen of reference drug product, it would make sense to develop a 150 mg strength even though the reference product does not have it. So, our generic drug product will have 3 strengths (150, 100 and 50 mg).
»
» PK linearity has been demonstrated in the range of that doses.

So far so good. Since you are mentioning RLD you are targeting the FDA, right?
Is a single (not daily) 150 mg dose approved?

» Should RLD 100mg VS Generic 100mg be done …

Yes. If a proportionality biowaiver (in vitro similarity) of the 50 mg strength works, fine. Check the product-specific guidance for the recommended conditions. If that fails, you need to perform a biostudy of the 50 mg strength as well.

» … or RLD 100mg + RLD 50mg VS generic 150mg?

For the FDA that’s an 505(b)(2) NDA (the guidance is quite old and not very specific); you can’t get an approval of the 150 mg via an ANDA since it not a generic (no 150 mg RLD). The study 150 mg (T) vs. 100 mg (RLD) + 50 mg (RLD) is just part of the story.
In Europe that’s the hybrid pathway. Additionally to this study generally clinical studies are required as well.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 6 (0 registered, 6 guests [including 3 identified bots]).
Forum time: Sunday 03:40 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5