505(b)(2) drug development pathway has steadily become more appealing to drug developers
With 505(b)(2) pathways, development times and FDA approval are accelerated, when compared to the 10-15 years for a traditional new chemical entity (NCE). In this article, we take a look at the 505(b)(2) drug development pathway and how we support clients pursuing 505(b)(2) products.
What is a 505(b)(2) drug product?
The FDA defines a 505(b)(2) application as:
“[A 505(b)(2) is] an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use, including, for example, the Agency’s finding of safety and/or effectiveness for a listed drug or published literature.”1
Drug development companies are therefore able to leverage existing regulatory data on an already approved NCE and supplement the package with new information relevant to their new product, typically with additional CMC and clinical data.
What are benefits of the 505(b)(2) pathway for developers?
For an innovator company, this repurposing of existing drugs can help manage the value of an NCE through its life cycle, with the benefit of reduced development time, cost, and risk. For a virtual or small drug delivery company, this approach enables innovative ideas to improve upon marketed products or dosage forms resulting in new products that provide benefits to patients.
What challenges need to be addressed when pursuing 505(b)(2) pathway?
In the high-stakes world of pharmaceutical drug development, reduced time and costs are a very attractive offering. 505(b)(2) programs can still present development challenges, particularly from a CMC perspective that do require careful consideration.
Understanding how to quickly identify the best formulation to move forward with, whether it is scalable for commercialization, and what key clinical studies are needed to generate the necessary pharmacokinetic, safety & efficacy data, are all factors that play a role in getting regulatory approval.
How do patients benefit from the 505(b)(2) drug development pathway?
From a patient perspective, the benefits of the 505(b)(2) pathway are multiple; improved formulations can lead to increased compliance and enhanced clinical outcomes, new routes of administration can offer greater convenience, and new therapeutic indications can address unmet clinical needs.
How to choose a CDMO for 505(b)(2) Drug Development?
To achieve a successful project outcome, one of the first and most critical steps is selecting the right development partner. Mid-sized to large pharmaceutical companies may be looking for a partner who can become an extension of their existing R&D capabilities. Virtual or small biotechs are likely to be seeking a partner that can provide expertise, resources, and capacity in multiple areas of drug development and specifically has experience in working with 505(b)(2) programs.
Quotient Sciences has significant experience developing 505(b)(2) drug programs, and we help clients turn their innovative ideas into successful products.
With facilities in the UK and US, and a global team of drug product experts, we can develop, characterize, manufacture, and evaluate new drug products from the early stages of drug development to commercial launch. We also offer the ability to accelerate the development of 505(b)(2) programs leveraging Translational Pharmaceutics to integrate CRDMO services.
For more information on our 505(b)(2) drug development capabilities, including how we can apply Translational Pharmaceutics, contact us today.
References
1. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/abbreviated-approval-pathways-drug-product-505b2-or-anda-september-19-2019-issue
2. US FDA, CDER, Draft guidance for industry applications covered by section 505(b)2). https://www.fda.gov/ downloads/Drugs/Guidances/ ucm079345.pdf. Published October 1999.
3. US FDA, CDER. Determining whether to submit an ANDA or a 505(b)2)application. https://www.fda.gov/regulatory-information/search-fdaguidance-documents/determining-whether-submit-anda-or-505b2-application. Published May 2019.
4. Freije, I; Lamouche, S; Tanguay M; Therapeutic Innovation & Regulatory Science, 1-11, 2019 DOI: 10.1177/2168479018811889 tirs.sagepub.com