End-to-End Program
Making Early-Phase Drug Development Faster, Better, and More Efficient
Early-phase drug discovery and drug development are complex processes, where many moving parts can, and do, influence the success of a program.
ISSUE NO. 6 — 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 European Union, the 505(b)(2) new drug application (NDA) approval process in the United States 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 Issue 6 of The Altascientist, we explore the 505(b)(2) NDA approval pathways and their benefits over generic approvals, relevant drug categories, and key strategies for market authorization:
- Applicable categories of drugs for hybrid or 505(b)(2) pathways
- Hybrid or 505(b)(2) vs. generics
- Choosing a drug candidate
- A case study: Achieving a 505(b)(2) Regulatory Approval