India Pharmaceuticals:FDA defines ways to ease complex generics approval

FDA provides ways to ease complex generics approvals: FDA has announced anew set of policies aimed at easing approvals of complex generic drugs and initiallyissued two draft guidance documents to support the development of complex generics.The FDA Commissioner, Scott Gottlieb, stated in his blog post on 2Oct, 2017that newpolicies are aimed to provide as much scientific and regulatory clarity as possible withrespect to complex generics given their increasing significance to the economic healthof the generic drug industry. Mr Gottlieb further stated that as part of ongoing broaderefforts, the FDA will work to develop more tools, methods, and efficient alternativeswherever feasible for reducing hurdles for complex generics and more guidancedocuments should be coming in the near-future.。

    What do guidance documents convey? The first draft document reflects a unifiedapproach to all formal meetings between FDA and ANDA filers for complex genericsand assists filers in generating and submitting to the FDA a meeting request (productdevelopment, pre-submission & mid-review cycle meetings) and the associatedmeeting package. These meetings will allow for enhanced communication betweenANDA filers and the FDA early in generic development process, thus allowing moreefficient development, review and approval pathways. The second draft documentaims to help submissions of ANDAs for certain specific synthetic peptides, referencebrands for which are manufactured using rDNA technology.。

    FDA addresses need of the hour for generic industry: Due to development andregulatory challenges, the complex generic space is relatively underpenetratedcompared to traditional generics (generic penetration in key complex drug classese.g. injectables, long-acting injectables, inhalers etc. range between 8-45%compared to more than 80% generic penetration in oral solids). A lack of establishedregulatory pathways has resulted in the entry of only a few players in recent complexgenerics approvals like gRenvela tab (Aurobindo, Dr Reddy’s), gLialda (Cadila), andgCopaxone 40mg (Mylan/Natco). Furthermore, only few players have tried or aretrying to develop generics for upcoming key opportunities like Advair Diskus,Suboxone Film, NuvaRing, Welchol, Nasonex, Canasa, etc (Refer page 3for details).Hence, we believe the FDA’s initiative is the much required move towards addressingthe need of the industry to drive earnings growth for generic players.。