New FDA requirements for generics trials

Home/Policies & Legislation | Posted 16/08/2013 post-comment0 Post your comment

As of January 2014 generics companies may be required to submit data for not just one batch, as is currently the case, but for three batches.

picture58

Although this is already the case for generics submitted to Europe, where EMA already requires safety, efficacy and stability data from three batches of any new generic drug, the change are expected to increase the costs of generics development by up to three times.

Additional requirements for extended studies of generic drugs are also being proposed by FDA, which will require new generics to be kept in real time conditions for 36 months.

The increased costs are being attributed mainly to the cost of the active ingredient – the greater the number of batches the greater more active ingredient is required. The total cost of generic drug development is estimated at around US$3 million per product.

Indian drugmakers such as Cadila Health, Dr Reddy’s Laboratories, Lupin, Ranbaxy and Sun Pharma each file around 15–20 abbreviated new drug applications (ANDAs) per year seeking approval from FDA. Smaller Indian generics companies such as Torrent Pharma and Alembic still file five to 10 ANDAs per year with FDA.

Despite the increased costs that may result from these additional requirements the US is a major market for Indian companies and is sure to remain a lucrative one. The US generics market is estimated to be worth around US$30 billion, of which Indian pharmaceutical companies account for 10% market share at US$3–3.5 billion.

Related article

Indian generics companies top ANDA approvals

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.

Source: Business Standard

comment icon Comments (0)
Post your comment
Related content
Public consultation for the modification of the biosimilars regulation
02 AA010638
Home/Policies & Legislation Posted 16/01/2024
COFEPRIS promotes regulatory cooperation in the Americas
Latin America 1638px
Home/Policies & Legislation Posted 12/12/2023
ANVISA's decision on 'Skinny labels' for generics pending
Labelling V14I26
Home/Policies & Legislation Posted 14/11/2023
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010