Hybrid Medicines And 505(b)(2) NDA Approval Pathways

Hybrid medicines are drugs based on a generic molecule and have a different route of administration, format, strength, or indication from the original reference product. They require re-approval for market authorization, partly based on data from the original reference medicine, and partly on data from new clinical trials on the modified version.

Like the Hybrid medicine authorization process in the EU, the 505(b)(2) NDA approval process in the USA applies to generic molecules that have a slight change from the reference medicine, and can use published data, including previous FDA submissions and communications, to support their re-approval by the FDA.

In 2019, more than 50% of New Drug Applications in the USA were 505(b)(2). According to the FDA's New Drug Therapy Approvals document, there were 64 505(b)(2) and 48 novel drugs approved that year alone, while in Europe the breakdown was similar. In its annual report, the EU reported 66 total approvals in the following categories:

• 30 Novel
• 36 Hybrid and abridged, generic, well-established use and informed-consent applications