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FDA cash to develop hard-to-copy generics Posted 06/03/2015

The US Food and Drug Administration (FDA) is offering US$850,000 to research teams working on generics development. Funds will be split between three programmes: bioequivalence testing for long-acting periodontal drugs; developing methods for assessing long-acting injectable generics; and dissolution methods for long-acting levonorgestrel intrauterine system. Funds may be extended for a further two years.

FDA hopes the research into generic long-acting injectables will develop better models for predicting how these drugs act in the body over an extended period. Developing generic injectables is notoriously difficult [1], which has left them with a significantly smaller market than traditional oral generics.

The agency highlights a lack of in vitro drug release assays for long-acting contraceptive intrauterine systems. It outlines a five-year study to investigate dissolution methods for the popular intrauterine contraceptive, levonorgestrel intrauterine system, to include detection of manufacturing differences and prediction of in vivo performance.

The results from this study will help FDA develop recommendations to determine bioequivalence of generic intrauterine systems. The agency released a new draft guidance document in 2014 on the bioequivalence requirements for the development of generic versions of Bayer’s intrauterine contraceptive Mirena (levonorgestrel) [2].

The application deadline for both programmes is 27 April 2015. FDA has said it will spend at least US$250,000 on developing methods for periodontal drugs and at least US$125,000 on developing methods for intrauterine drug systems. The research will be part of an ongoing FDA initiative to encourage bioequivalence testing and generic development of more complex and hard-to-copy therapies.

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1.   GaBI Online - Generics and Biosimilars Initiative. Growing generic injectables market: a cousin to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 6]. Available from: www.gabionline.net/Generics/News/Growing-generic-injectables-market-a-cousin-to-biosimilars 
2.   GaBI Online - Generics and Biosimilars Initiative. FDA releases bioequivalence guidance for 26 generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 6]. Available from: www.gabionline.net/Guidelines/FDA-releases-bioequivalence-guidance-for-26-generics 

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Source: NIH

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