US guidelines for follow-on NBCDs Posted 10/06/2016

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 The agency has, however, issued draft guidance documents for certain NBCD families, e.g. liposomes, different iron carbohydrates (iron sucrose, iron gluconate, ferumoxytol) and cyclosporine ophthalmic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The FDA has not yet finalized any guidelines for follow-on NBCDs, but the agency has the following draft guidance for certain NBCD families: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 Overarching Draft Guidance
These guidance documents contain information relevant for NBCD families and are applicable to both originator and follow-on NBCDs:

Liposome Drug Products
Date: October 2015
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070570.pdf

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 Specific Draft Guidance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

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

Iron Sucrose
Date: November 2013
www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm297630.pdf

Iron Gluconate
Date: June 2013
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358142.pdf

Ferumoxytol
Date: December 2012
www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm333051.pdf

Cyclosporine (Emulsion/Ophthalmic)
Date: June 2013
www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm358114.pdf

Sevelamer Carbonate
Date: September 2015
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm089620.pdf

Glatiramer acetate
Date: April 2016
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495029.pdf

Related article
EU guidelines for follow-on NBCDs

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Source: US FDA

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