US guidelines for follow-on NBCDs

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US guidelines for follow-on NBCDs

Non‐Biological Complex Drugs/Guidelines | Posted 10/06/2016 0 Post your comment

Last update: 1 June 2018

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

Like biologicals, non-biological complex drugs (NBCDs) consist of different (closely related) structures that cannot be fully quantitated, characterized or described by (physico)chemical analytical tools. The composition and quality of NBCDs are dependent on the manufacturing process and controls – just as is the case with biologicals.

The FDA does not formerly recognize NBCDs, with originators required to follow the new drug application (NDA) route and follow-on NBCDs using the generics – abbreviated new drug application (ANDA) – route. The agency has, however, issued draft guidance documents for certain NBCD families, e.g. liposomes, different iron carbohydrates (iron sucrose, iron gluconate, ferumoxytol) and cyclosporine ophthalmic emulsions.

The FDA has not yet finalized any guidelines for follow-on NBCDs, but the agency has the following draft guidance for certain NBCD families:

1. Overarching Guidance
These guidance documents contain information relevant for NBCD families and are applicable to both originator and follow-on NBCDs:

Liposome Drug Products
Date: April 2018
https://www.fda.gov/downloads/drugs/guidances/ucm070570.pdf

2. Draft Overarching Guidance
These guidance documents contain information relevant for NBCD families and are applicable to both originator and follow-on NBCDs:

Cyclosporine Drug Products
Date: February 2016
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358114.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

3. Draft Specific Guidance
These guidance documents are specific to the type of NBCD and contain recommendations on how to demonstrate bioequivalence for follow-on NBCDs:

Amphotericin B
Date: April 2014
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384094.pdf

Bupivacaine
Date: February 2018
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM586176.pdf

Daunorubicin citrate
Date: July 2014
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406256.pdf

Doxorubicin Hydrochloride
Date: December 2014
www.fda.gov/downloads/Drugs/.../Guidances/UCM199635.pdf

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EU guidelines for follow-on NBCDs

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Source: US FDA