Skip to main content
505(b)(2) , Regulatory

What Is 505(b)(2)? Choosing a partner to accelerate the development of 505(b)(2) drug products

Translational Pharmaceutics Now With Drug Substance - Quotient Sciences

What is a 505b2 Drug Product?

The 505(b)(2) development pathway has steadily become more appealing to drug developers as development times and FDA approval are accelerated compared to the 10-15 years for the traditional new chemical entity (NCE) .  

The FDA defines a 505(b)(2) application as “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. 

Benefits of the 505(b)(2) 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.  

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. 

In the high-stakes world of pharmaceutical drug development, reduced time and costs are a very attractive offering, however, 505(b)(2) programs can present some unique 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. 

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.

Our 505(b)(2) Expertise

Quotient Sciences has significant experience in developing 505(b)(2) drug programs and we help our customers turn their innovative ideas into successful products. With state-of-the-art facilities in the UK and US and a global team of drug product and clinical experts, we have the expertise to develop, characterize, manufacture, and evaluate new drug products in the early stages of drug development all the way through to commercial launch.

We also offer our customers the ability to accelerate the development of their 505(b)(2) programs by leveraging our unique platform called- Translational Pharmaceutics™ which integrates formulation development, real-time adaptive manufacturing, and clinical testing.  Each program is led by a single project manager and incorporates rapid “make-test” cycles, where drug products are manufactured, released, and dosed in days or weeks rather than months, thus shortening the time for clinical data. Decisions are driven by human data, which not only optimizes the formulation but also multiplies the likelihood of success.

A recent publication by the Tufts Center for the Study of Drug Development compared timelines from traditional multi-vendor outsourcing used in industry to Translational Pharmaceutics and the study concluded that Translational Pharmaceutics saved at least 12 months of development time. This amounted to multi-million dollar financial benefits in the form of reduced R&D costs and earlier revenues from product sales.

For more information on our 505(b)(2) drug development capabilities, contact us.




2. US FDA, CDER, Draft guidance for industry applications covered by section 505(b)2). downloads/Drugs/Guidances/ ucm079345.pdf. Published October 1999.

3. US FDA, CDER. Determining whether to submit an ANDA or a 505(b)2)application. Published May 2019.

4. Freije, I; Lamouche, S; Tanguay M; Therapeutic Innovation & Regulatory Science, 1-11, 2019 DOI: 10.1177/2168479018811889