FDA’s faster approval of generics to benefit Indian drugmakers Posted 02/06/2014

Indian generics makers are set to benefit from performance goals set by the US Food and Drug Administration (FDA) as part of the Generic Drug User Fee Amendments of 2012 (GDUFA).

The user fees collected under the GDUFA will enable FDA to reduce its current backlog of pending applications, cut the average time required to review generics applications for safety and increase the number of inspections it carries out [1].

The performance goals outlined in the GDUFA require FDA to review 60% of generics applications submitted as abbreviated new drug applications (ANDAs) within 15 months. The agency intends to achieve this goal by financial year (FY) 2015, which begins on 1 October 2014 and ends on 30 September 2015. FDA has set further goals for FY 2016 and 2017 to review 75% of ANDAs within 15 months and 90% of ANDAs within 10 months, respectively.

This reduction in review times, from the currently reported rate of approximately three years to review ANDAs, is expected to help companies bring generics to the US market faster, thus increasing competition and thereby reducing prices.

Indian drugmakers expected to gain from FDA’s reduction in review times include Cadila Healthcare, Dr Reddy’s Laboratories, Glenmark, Lupin Pharmaceuticals, Sun Pharmaceutical Industries and Torrent Pharma, all of which have a significant presence in the US$30 billion generics market in the US.

Early penetration of generics from more drugmakers is expected to facilitate faster price erosion, which is not necessarily a good thing for generics majors such as Mylan, Sandoz and Teva, who are likely to face increased competition from other generics makers entering early and vying for a larger market share.

Indian generics makers account for 10–12% of the total US generics market.

Related articles

FDA increases generic drug user fees in 2014

FDA gives details of generic drug user fees

Generic drug user fees come into effect


1.   GaBI Online - Generics and Biosimilars Initiative. FDA gives generics greater importance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 2]. Available from: www.gabionline.net/Generics/General/FDA-gives-generics-greater-importance

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 © 2014 Pro Pharma Communications International. All Rights Reserved.

Source: FDA, Indian Business Standard

Comments (0)