End-to-End Program
Five Things You Need to Know About Partnering with an Integrated CRO/CDMO
We are often asked about the advantages of working with an integrated CRO/CDMO.
Five Ways Altasciences Simplifies the Drug Development Process for You
Bringing new drugs to market, from lead candidate selection through preclinical testing, to clinical proof of concept, is a complex, time-consuming, and costly process.
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
Hybrid or 505(b)(2) versus Generic Pathways
Medicines approved via the hybrid or 505(b)(2) regulatory pathways have certain market advantages over generics. Because hybrid medicines deliver additional benefits compared to the reference product (a new delivery system, different formulation, new indication, etc.,) they can be branded, and marketed, with attention to the advancements they bring to treatment.
Generic medicines are considered equivalent to their reference products and, as such, cannot be branded or marketed on their features. Their product insert and safety information are identical to that of the reference product. Generics compete on price, while hybrid or 505(b)(2) products compete based on the improvements they offer (i.e., ease of use, safety, or efficacy). The submission requirements for both types of products also differ, which is why pre-submission meetings with regulatory bodies are essential and serve to establish the exact data sets required.
Altasciences has decades of experience conducting research for modified drugs taking the hybrid or 505(b)(2) approval pathway. In fact, since 2010, we have designed and conducted more than 250 studies that followed these pathways.
Get in touch today to see how we can support your 505(b)(2) application!