FDA Funding Opportunities to Spur Development of Hard-to-Copy Drugs

Sunday, March 1, 2015

Source: FDA News

The FDA is pushing ahead with efforts to spur development of hard-to-copy generics, this time sponsoring research into bioequivalence testing for long-acting periodontal drugs and developing methods for assessing generic, long-acting injectables.

In total, the agency is offering up to $850,000 in grants to drugmakers or researchers this year to study the two topics. Additional funds may be available in the next two years.

The agency hopes the research into long-acting injectables will develop better models for predicting how such products will act in the body over the extended period during which they are intended to release API.

For periodontal drugs, meanwhile, the agency wants to develop dissolution test methods that will reliably account for variables in inactive ingredients and manufacturing processes of the generics versus the reference drug,

Applications for the grant money under both programs are due April 27, and are part of the ongoing agency initiative to encourage BE testing and generic development of more complex and hard-to-copy therapies, which can still elude generics makers.

The agency’s regulatory science priorities for the current fiscal year include developing equivalence testing of such drugs, and they were among the top priorities outlined in the agency’s $50 million annual research budget announced last May.

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