It is clear the FDA recognizes the range of development possibilities made possible by the 505(b)(2) pathway, as illustrated by the recently released draft guidance for the development of depot buprenorphine products for treatment of opioid-use disorder. What is striking about this guidance is that it attempts to address all possible approaches to achieving the same basic goal of marketing a depot buprenorphine product. The FDA guidance illustrates the breadth of potential options for developing a product under the 505(b)(2) regulatory pathway.

The Premier Consulting team works with sponsors to develop innovative pharmaceuticals on development programs with a wide range of complexity. This is, in part, because of the full breadth of possible 505(b)(2) development programs, which includes a range from paper-only submissions to nearly full development programs.

505(b)(2) Development Range of Options

A generic copy under 505(j) of a depot injection is difficult to develop due to the use of proprietary technologies and other forms of market protection for innovator products. Follow-on products targeting therapeutic equivalence to those innovators often leverage the flexibility of the 505(b)(2) pathway. These “equivalent” products are among the most minimal 505(b)(2) development programs, though it is important to point out that “minimal” does not always mean easy.

Alternatively, the Agency recognizes that some Sponsors may want to differentiate their product from the innovator, for example, by improving upon the safety and / or efficacy profile of the product. Newer and better products benefit patients, but they come with additional study requirements to support that differentiation. The goal for this business model is to invest more up front to take a greater share of the premium pricing market by showing that the new product is superior to the currently marketed alternatives.

The Agency appears to recognize and address at a high-level the range of development paths and potential requirements for this specific type of product in this one draft guidance. This single example from the FDA illustrates the various approaches that can be taken and the business models that can be accommodated by the 505(b)(2) development pathway.

Importance of Expertise

Premier Consulting has expertise in leveraging the flexibility of the 505(b)(2) pathway to help bring a range of valuable products to the market in the most efficient way possible. With experience in more than 1100 Agency meetings, Premier Consulting’s multidisciplinary teams work to maximize the potential of every sponsor’s project. By incorporating our understanding of the commercial, regulatory, medical, and scientific requirements, Premier Consulting helps sponsors navigate the best path forward to meet their needs and goals.

As the global 505(b)(2) experts, Premier Consulting specializes in developing and delivering faster, lower cost, and lower risk programs. For more about the range of options available for a therapeutic’s development via the 505(b)(2) pathway and how to apply those options to your program, contact us.