When to Submit an ANDA vs. a 505(b)(2)? FDA Explains

Regulatory NewsRegulatory News
| 09 May 2019 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Thursday finalized guidance to help drug sponsors determine when they should submit an abbreviated new drug application (ANDA) for a generic or a 505(b)(2) application for a drug that partly relies on certain data from an already-approved drug.

Generics approved via ANDAs are common, with hundreds of approvals coming each year, whereas examples of drugs approved under the 505(b)(2) pathway may be less well known but include approvals such as Adapt Pharma’s Narcan nasal spray or follow-on insulin products like Eli Lilly’s Basaglar and Sanofi’s Admelog.

The guidance finalizes a draft from October 2017 and includes minor revisions, including a reworking of a section on scientific considerations for ANDAs and 505(b)(2) applications.

“We note that we received comments requesting clarification on the process for obtaining therapeutic equivalence evaluations. We will address therapeutic equivalence in a forthcoming guidance document,” FDA said in Thursday’s Federal Register.

Differences Between ANDAs and 505(b)(2)

Both ANDA and 505(b)(2) applicants have significant flexibility in the types of studies, data and information they may submit, the guidance says, although ANDA applicants should not submit clinical investigations to establish safety and effectiveness.

FDA further explains how a 505(b)(2) applicant may rely on FDA’s finding of safety and/or effectiveness for a listed drug only to the extent that the proposed product in the 505(b)(2) application shares certain characteristics (e.g., active ingredient, dosage form, route of administration, strength, indication or other conditions of use) with the relied-upon listed drug.

“The applicant is expected to establish a bridge (e.g., by using comparative bioavailability data) between the proposed drug product and each listed drug that the applicant seeks to rely upon to demonstrate that reliance on the listed drug is scientifically justified. To the extent that the listed drug and the drug proposed in the 505(b)(2) application differ (e.g., a product with a different dosage form or a product that is intentionally more bioavailable than the listed drug), the 505(b)(2) application must include sufficient data to support those differences,” the agency says.

The guidance also spells out what to do when there are intentional differences between the proposed drug and reference-listed drug, including differences in formulation, bioequivalence and/or bioavailability and conditions of use.

As far as who to contact at FDA with questions, the guidance notes that ANDA applicants should submit controlled correspondence to the Office of Generic Drugs (OGD) or request a pre-ANDA meeting with OGD if they are developing a product that is intended to have the same active ingredient(s), conditions of use, route of administration, dosage form, strength and (with certain permissible differences described in the guidance) labeling as a reference listed drug.

And if an applicant is developing a product that has a “different active ingredient, conditions of use, route of administration, dosage form, strength, or labeling than a listed drug and/or is proposing a clinical study program and has questions about submission of an application through the 505(b)(2) pathway, the applicant should contact the appropriate Office of New Drugs review division for assistance,” the guidance says.

Determining Whether to Submit an ANDA or a 505(b)(2) Application: Guidance for Industry


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