The FDA just announced it’s released new documents that’ll make it easier for generics manufacturers to compete with 38 innovator drugs – including popular ones like Kalydeco, Belviq, Stendra and Brilinta, RAPS reports.
Called bioequivalence recommendations, these documents will help support generics applying for ANDAs , so as to hasten the development of a cheaper alternative for these drugs. RAPS writes:
Generic drugs, unlike new drugs, may be approved by FDA by showing that they are (among other things) bioequivalent to the drug they intend to reference. Bioequivalence can be shown in relatively small trials involving human subjects, which permits a company to avoid much larger—and much more expensive—full clinical trials required of new drug substances.
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
The guidance tells generic drugmakers what kinds of studies are needed to achieve regulatory approval. See the entire list of drugs – and their respective generic approval roadmaps – here.
