Opinion: Improving the FDA-EMA parallel scientific advice program to advance complex generics

Off-patent medicines provide people with access to high-quality essential treatment options that can be significantly less expensive than branded on-patent medicines. Off-patent therapies — generics and biosimilars — represent a system-critical industry that delivers around 80% of medicines used worldwide at a fraction of the cost of branded medicines.

A growing area of focus is on the development of complex generics. These include products with complex active ingredients and complex drug-device combinations, among others. Complex generics are typically difficult to develop, regulatory pathways for them can be convoluted, and the regulatory frameworks differ across health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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