US agency proposal would harmonize scientific and technical standards for generic drugs.
Current requirements for receiving approval to market generic drugs in different countries, while generally similar, often include small differences that can lead generic drug developers to limit the number of countries they target for approvals.
The US Food and Drug Administration would like to make it easier for generic drug manufacturers to obtain marketing approval in multiple countries with one application. The agency has submitted a proposal to the International Council on Harmonisation or ICH — for better unifying scientific and technical standards for generic drugs that would facilitate simultaneous approvals in multiple markets.
The goal is to “make it easier for developers that would otherwise only seek generic drug approval in one region to also seek approval in the United States, increasing competition in America. And it would also make it easier for developers that would otherwise only seek generic drug approval in the US market to gain access to other markets,” said FDA commissioner Scott Gottlieb.
The FDA proposal includes the development by ICH of a series of guidelines on standards for demonstrating bioequivalence for both non-complex and complex dosage forms and drug products. The agency is hopeful the ICH Assembly will endorse the proposal at its next meeting in November 2018.
Separately, the results of a recent FDA study suggest that there are significant opportunities for generic drugs in markets where they are currently not sold, particularly for generic drugs in countries where only the branded counterpart is available.