R and D Intelligence in 5 Sec- 237 Original 505(b)(2) Approvals used Published Literature as Evidence for Approval
Approval under section 505(b)(2) is one of the three types of accepted new drug applications*:
an application that contains full reports of investigations of safety and effectiveness but 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 (section 505(b)(2))
It is possible for applicants to substantiate safety and effectiveness based on existing data including published literature. A client recently asked us, how many new 505(b)(2) applications approved by the FDA where at least some of the information required for approval comes from “Published Literature”?
Vivpro found 27% (237 of 880) of 505(b)(2) applications (approved as original applications) where at least some of the information required for approval comes from “Published Literature”. We also found that 40% (96 of 237) of applications used “Published Literature” as the only supportive evidence with or with new studies.
A 505(b)(2) approval pathway has some advantages of a regular NDA (505(b)(1)) and Generics (505(j)). On the other hand, the opportunity creation, product strategy, regulatory strategy, and commercial viability are equally, if not more, challenging compared to regular NDA applications.
Vivpro believes this pathway should be central to all life cycle management strategies and appears to be underutilized despite its potential for 3–7 years of exclusivity, lower risk, lower costs compared to full NDA.
