A 505(b)(2) is a new drug application which contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant. This pathway gains approval in a fraction of the time at a potentially lower risk than the traditional 505(b)(1) path. The 505(b)(2) pathway can provide relatively fast approval for a wide range of products, especially for those that represent a limited change from a previously approved or existing drug such as reformulations and new routes of administration.
The Growing Importance Of 505(b)(2) Today
In the fiscal year 2006, approximately 20% of new small-molecule drugs were approved through the 505(b)(2) process; two years later, more than half of the small-molecule new drugs approved in the United States were based on this strategy. Judging from the rate at which investigational new drug (IND) applications are being filed today, it is expected that the percentage of 505(b)(2) approvals will be greater than 80% within the next few years. The reasons behind the remarkable success of the 505(b)(2) process are manifold, including:
Because approval can rest in part on publicly available data, smaller and fewer studies are required, thus mitigating costs and shortening development time.
Unlike generic drugs approved under Section 505(j) where exclusivity can be held for only 180 days, the 505(b)(2) applicant may qualify for three, five, or even seven years of market exclusivity, depending on the type of clinical data included in the NDA (new drug application).
In the relatively few years since clearing legal hurdles for 505(b)(2), the process has rendered significant changes on the drug development landscape. Today, as the patents for many blockbuster drugs and perhaps 100 other protected drugs are set to expire, smart marketers are seeking ways to create new, differentiated products, new market niches, and marketing exclusivity — 505(b)(2) provides just that.
A Solution For Market Exclusivity
The 505(b)(2) path allows a sponsor to get out of the competitive environment of generics while still enjoying a development process that eliminates most preclinical studies as well as extensive safety and efficacy tests. Additionally, the 505(b)(2) process can be more attractive to investors because the product differentiation can provide significantly better market potential. The rising tide of drugs approved under this strategy is testament to its growing importance in the drug development market.
Phelps is president and CEO of Camargo Pharmaceutical Services. As an expert in drug development, specifically 505(b)(2), he used more than three decades of experience in the health science and services industry to found Camargo Pharmaceutical Services in 2003.
SOURCE: Camargo Pharmaceutical Services