FDA: Makers Of Interchangeable Drugs Can Use Biosimilar Process For Manufacturing Changes

A new FDA guidance details a process for how manufacturers of biosimilar and interchangeable drugs should notify the agency of manufacturing changes similar to the process laid out in the Public Health Service Act for innovator drugs, telling drug makers they must demonstrate that the biosimilar or interchangeable remains comparable to its reference product and does not lose quality, safety or efficacy. FDA published a guidance providing manufacturers with recommendations on what information they should provide to FDA in support...