21
Feb
2024
What is the difference between 505j application, 505b1 NDA & 505b2 NDA?
In this topic we will be discussing about 505j, 505b1 and 505b2 application and differences between all 3 applications. The 505(j), 505(b)(1), and 505(b)(2) applications are pathways under the Federal Food, Drug, and Cosmetic Act (FDCA) for gaining FDA approval for drugs.
505(j) Application
A generic application.
- A 505(j) application is an abbreviated new drug application (ANDA) that contains information to show that the proposed product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics and intended use, among other things, to a previously approved product – the reference listed drug (RLD).
- ANDAs do not contain clinical studies as required in NDAs but are required to contain information establishing bioequivalence to the RLD.
- A drug product that is the subject of an ANDA is referred to as a generic drug.
505(b)(1) NDA
A 505(b)(1) application is an application that contains full reports of investigations of safety and effectiveness.
- The investigations the applicant relied on for approval were conducted by or for the applicant or the applicant has obtained a right of reference or use for the investigations.
- Full application – Data predominantly obtained from studies conducted by the sponser.
505(b)(2) NDA
Hybrid between an ANDA [505(j)] and full NDA [505(b)(1)].
- A 505(b)(2) application is an application submitted under section 505(b)(1) for which the investigations the applicant relied on for approval were not conducted by or for the applicant and the applicant has not obtained a right of reference or use for the investigations (21 U.S.C. 355(b)(2)).
- Section 505(b)(2) expressly permits FDA to rely, for approval of an NDA, on data not developed by the applicant – such as published literature or the agency’s finding of safety and/or effectiveness of a previously approved drug product.
Comparison of 505j 505b1 and 505b2 [Royed Training]
| wdt_ID | wdt_created_by | wdt_created_at | wdt_last_edited_by | wdt_last_edited_at | Aspect | 505(j) - ANDA (Abbreviated New Drug Application) | 505(b)(1) - NDA (New Drug Application) | 505(b)(2) - NDA (New Drug Application) |
|---|---|---|---|---|---|---|---|---|
| 1 | roysr | 01/10/2024 03:00 PM | roysr | 01/10/2024 03:00 PM | Purpose | For approval of a generic drug. | For approval of a new drug with full clinical trials. | For approval of a new drug with some existing data. |
| 2 | roysr | 01/10/2024 03:00 PM | roysr | 01/10/2024 03:00 PM | Clinical Trials | No clinical trials needed. Bioequivalence to the reference listed drug (RLD) must be shown. | Full clinical trials are required to demonstrate safety and efficacy. | May rely on existing clinical data (from literature or previously approved drug) with some additional trials. |
| 3 | roysr | 01/10/2024 03:00 PM | roysr | 01/10/2024 03:00 PM | Data Requirements | Demonstrates that the generic is bioequivalent to the branded reference product. | Full preclinical and clinical data to support safety and efficacy. | Uses existing studies or data from a previously approved drug, with supplemental data from new studies if necessary. |
| 4 | roysr | 01/10/2024 03:00 PM | roysr | 01/10/2024 03:00 PM | Patent Issues | Must certify that the generic drug does not infringe on any valid patents or that those patents are invalid/expired. | Must include a complete patent certification if applicable. | Must certify against the patents of the reference drug; can also include data to support differences from the reference product. |
| 5 | roysr | 01/10/2024 03:00 PM | roysr | 01/10/2024 03:00 PM | Eligibility | Drug must be identical to the RLD in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics, and intended use | For new drugs or novel formulations | For new drugs or novel formulations, especially those with modifications like new dosage forms, strengths, or indications |
| 6 | roysr | 01/10/2024 03:00 PM | roysr | 01/10/2024 03:00 PM | Market Exclusivity | No exclusivity unless a Paragraph IV challenge is made and won (180 days of exclusivity). | Typically grants 5 years of exclusivity for a new chemical entity (NCE). | 3 years of market exclusivity for significant modifications (formulation changes, new indication, etc.) if additional clinical data are required. |
| 7 | roysr | 01/10/2024 03:00 PM | roysr | 01/10/2024 03:00 PM | Innovation | No innovation; it’s a copy of an already approved drug. | Usually for new chemical entities or entirely new formulations. | Allows for modification of an already approved drug (e.g., new formulation, delivery method, or indication). |
| 8 | roysr | 01/10/2024 03:00 PM | roysr | 01/10/2024 03:00 PM | Review Time | Shorter review time (usually around 10 months). | Typically longer (up to 12 months or more). | Review time depends on the complexity, typically shorter than 505(b)(1). |
| 9 | roysr | 01/10/2024 03:00 PM | roysr | 01/10/2024 03:00 PM | Costs | Lower development and submission costs. | Higher due to the requirement for full clinical studies (higher than 505j and 505b2) | Mid-range cost, as some existing data can be leveraged (Can be lower than 505(b)(1) due to reliance on existing data) |
| 10 | roysr | 01/10/2024 03:00 PM | roysr | 01/10/2024 03:00 PM | Time to Market | Generally faster than 505(b)(1) or 505(b)(2) | Longer than 505(j), but shorter than 505(b)(1) | Can be shorter than 505(b)(1) due to reliance on existing data |
| Aspect | 505(j) - ANDA (Abbreviated New Drug Application) | 505(b)(1) - NDA (New Drug Application) | 505(b)(2) - NDA (New Drug Application) |
Summary:
- 505(j) ANDA: Used for generic drugs that are bioequivalent to a branded drug with no need for new clinical trials.
- 505(b)(1) NDA: For new drugs with full clinical data showing safety and efficacy.
- 505(b)(2) NDA: For modified drugs relying on existing data, requiring fewer new studies.
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