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Applicability of reference-scaling [Regulatives / Guidelines]

posted by Helmut Homepage - Vienna, Austria, 2017-05-10 14:10  - Posting: # 17343
Views: 14,710

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.



Cheers,
Helmut Schütz
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