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# AAM Wants Case-by-Case 505(b)(2) Determinations
- URL: https://www.fdaweb.com/aam-wants-case-by-case-505-b-2-determinations/
- Published: 2018-06-07T12:00:00.000Z
- Updated: 2026-09-15T00:11:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141634

The Association for Accessible Medicines (AAM) and its Biosimilars Council says FDA should take a case-by-case approach in determining whether a 505(b)(2) biological product is deemed to be a 351(a) or 351(k) biologic. AAM says this should be an administrative transition so products can retain all indications, strengths, and dosage forms for which they are already approved.

The AAM position is in its supplemental [comments](https://www.regulations.gov/contentStreamer?documentId=FDA-2015-D-4750-0018&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) to an FDA draft guidance on implementation of the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2009.

Although the topic did not arise in its initial response, AAM said it wanted to respond to a Lilly comment arguing that all approved 505(b)(2) applications for transitional biological products should be deemed to be approved 351(a) applications after the 3/23/20 transition date in the BPCIA.

AAM says Lilly’s position “fails to recognize the wide diversity of products that are approved via the 505(b)(2) pathway. While some 505(b)(2) products may fit more comfortably in the 351(a) category, others are more akin to biosimilars and interchangeable biological products approved via 351(k) of the BPCIA. Furthermore, given the broad variety of 505(b)(2) biologics and their evolution over time, it is possible that a given product may not fit perfectly into either a 351(a) or 351(k) category.”