Introduction to 505(b)(2) Commercialization

Throughout my career I have worked with 505(b)(1) (innovative), 505(b)(2) (value-added) and 505(j) (generic) products. Because of their unique nature, 5 years ago, I co-founded  the first business alliance for 505(b)(2) developers and marketers, which is now being renamed the Value-Added Medicines Alliance. From now through the end of the year I plan to write a blog about commercializing 505(b)(2) products and the unique challenges associated with this class of pharmaceutical products.

505(b)(2)s are often thought of in terms of easier/less risky products to develop by product developers. While in the market 505(b)(2)s are often labeled as glorified generics. In actuality, 505(b)(2)s are products that require a great deal of commercialization expertise to launch and successfully market. In baseball terms, the vast majority of 505(b)(2) products never become home runs, but they can make a good single or double.

The biggest asset of a 505(b)(2) is its brandability. Far too often 505(b)(2) product developers overlook the commercialization process needed to properly advantage a 505(b)(2) in the market so it can maximize speed to peak sales. When it comes to launch and marketing the lack of proper commercialization development is akin to the difference of a stand still start to a rolling start in a small engine car. A car with smaller engine can get up to speed faster with a rolling start than from a standstill start. In fact, the pressure put on the small engine to get up to speed from a stand still can put extreme stress on the engine that can require costly repairs in the future.

A 505(b)(2) product that does not create and implement a commercialization plan well before launch is creating a long-term issue that will result in less than optimal revenues for the life of the product. Throughout the next few months I will continue to blog on this topic and get into more specific areas including the importance of pre-launch efforts, product velocity, value-add differentiation, and marketing efficiency in commercializing a 505(b)(2) product.

Is your 505(b)(2) ready for commercialization? Omni-HC specializes in navigating the unique commercialization challenges of value-added medicines. To learn more go to www.omni-hc.com/505b2commercialization.html.