FDA facilitating generic versions of complex drugs

FDA released new guidance documents Thursday that are intended to facilitate generic competition for “complex,” hard-to-copy drugs. It issued product-specific guidance on 19 complex medicines, including six that have no generic competition. The drugs are considered complex to replicate by generic drugmakers because they typically cannot be assessed with traditional bioequivalence assays.

In a statement announcing the new guidance documents, FDA Commissioner Scott Gottlieb reiterated his intention to foster generic competition to complex drugs. FDA’s traditional approaches to such products “has discouraged competition,” Gottlieb said. “It’s meant branded drugs have enjoyed monopolies long after their patents and exclusivities have lapsed.”...