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

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 The agency has, however, issued draft guidance documents for certain NBCD families, e.g. liposomes, different iron carbohydrates (iron sucrose, iron gluconate, ferumoxytol) and cyclosporine ophthalmic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 The FDA has not yet finalized any guidelines for follow-on NBCDs, but the agency has the following draft guidance for certain NBCD families: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
Liposome Drug Products
2. Draft Overarching Guidance
Cyclosporine Drug Products
3. Draft Specific Guidance
Amphotericin B
Bupivacaine
Daunorubicin citrate
Doxorubicin Hydrochloride
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These guidance documents contain information relevant for NBCD families and are applicable to both originator and follow-on NBCDs:
Date: April 2018
https://www.fda.gov/downloads/drugs/guidances/ucm070570.pdf
These guidance documents contain information relevant for NBCD families and are applicable to both originator and follow-on NBCDs:
Date: February 2016
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358114.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery
These guidance documents are specific to the type of NBCD and contain recommendations on how to demonstrate bioequivalence for follow-on NBCDs:
Date: April 2014
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384094.pdf
Date: February 2018
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM586176.pdf
Date: July 2014
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM406256.pdf
Date: December 2014
www.fda.gov/downloads/Drugs/.../Guidances/UCM199635.pdf
EU guidelines for follow-on NBCDs
Source: US FDA
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