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Approval Pathways for Complex Generics – 505(j) vs. 505(b)(2)

Tuesday, November 9, 2021

1:30 p.m. - 2:30 p.m.

As an alternative to 505(j), 505(b)(2) may be a viable pathway for improving access to complex generics such as drug-device combination products, and particularly for complex products that may be subject to qualitative and quantitative (Q1/Q2) requirements that require them to be the same as the reference listed drugs (RLD). Strict adherence to Q1/Q2 sameness is not essential in most cases to ensure the safety or effectiveness of generic drugs, and requiring it unnecessarily has significant downsides and costs for the development and approval of complex generics. Section 505(b)(2) does not require Q1/Q2 sameness for approval and would allow complex generics to come to market more quickly and at lower cost without compromising safety or effectiveness. Using 505(b)(2) could further improve access to complex generics if FDA implemented a policy to assign therapeutic equivalence evaluation (TEE) codes to 505(b)(2) products upon approval at the applicant’s request.

Moderator: Kurt Karst, JD
Director, Hyman Phelps & McNamara

Michael Brzica
Vice President of Government Affairs, Teva Pharmaceuticals

Craig Burton
Vice President, Policy, AAM

Ripen Misri, PhD
Director, Co-Development, Apotex Inc.

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