Applicability of reference-scaling [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-05-10 12:10  – Posting: # 17343
Views: 17,702

Hi nobody,

» » Nobody knows how to deal with this story. :-(
» ... sorry, no.

Didn’t mean you. Nobody nobody (case sensitive). ;-)

» […] At least you need to write a new, Chapter 2.5-like overview on the pk, pharmacology, safety to make the assessor sleep well next night after reading your application for a generic. On the other hand, assessors for originator's MAs have a much, much better sleep (better sleeping pills?), in my experience...

Well, maybe assessors should take stimulants instead of sleeping pills. Les Benet’s claim “HVD(P)s are safe drugs” was based on two arguments:
  1. If an HVD(P) does not have a flat dose-response curve, there would have been safety/efficacy issues in phase III and the originator’s product would not get approved.
  2. No safety/efficacy issues were found in clinical practice.
    • OK, we all know that pharmacovigilance isn’t very sensitive and the system not well implemented in some countries. However, 32% of 222 novel therapeutics were affected by a postmarket safety event.*
Hence, I would rather say:

Reference-scaling for the innovator’s product

  1. Should not be allowed when scaling up to the production batch size.
  2. Should not be allowed for major formulation changes for a certain time after approval (e.g., five years).
  3. If there were no relevant issues, it should be allowed.
    Easy for the FDA because the product-specific guidance is issued fast and updated regularly.
    Takes a while for the EMA, but some already exist (e.g., posaconazole).

Reference-scaling for a generic product

Just my two ¢ worth.

Helmut Schütz

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

Complete thread:

 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,404 posts in 4,122 threads, 1,323 registered users;
online 12 (0 registered, 12 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 16:33 UTC

Those people who think they know everything
are a great annoyance to those of us who do.    Isaac Asimov

BEBAC Ing. Helmut Schütz