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Non‐Biological Complex Drugs

Multiple Sclerosis V14A24

Warning letter causes delays for follow-on glatiramer acetate

Non‐Biological Complex Drugs/News | Posted 17/03/2017

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 17 February 2017 that Sandoz’s contracted fill/finish manufacturing partner, Pfizer, had received a US Food and Drug Administration (FDA) warning letter.

Question-Fimea-V15E29

Is the EU ready for non-biological complex drug products?

Non‐Biological Complex Drugs/Research | Posted 03/03/2017

The definition of non-biological complex drugs (NBCDs) is not officially recognized, and there is no corresponding term, in the European Union (EU) pharmaceutical legislation or scientific guidance. Despite this, authors Falk Ehmann and Ruben Pita argue in their personal capacity that the existing EU legislation and guidance is equipped to adequately assess the quality, safety and efficacy, as well as the lifecycle management, of such a group of medicinal products [1]. While agreeing with most of Ehmann and Pita, a number of experts from the Steering Committee members of the NBCD Working Group pointed out that there are still many unknowns when it comes to NBCDs [2].

Nanoparticle V13J18

Follow-on versions of glatiramer acetate in Russia and Europe

Non‐Biological Complex Drugs/News | Posted 24/02/2017

US generics company Alvogen announced in September 2016 that it had launched a follow-on version of glatiramer acetate in Central and Eastern Europe. Then in November 2016, Russia’s Biocad announced that it had completed registration for its follow-on glatiramer acetate product in Russia.

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Non-biological complex drugs and pharmacopoeias

Non‐Biological Complex Drugs/Research | Posted 10/02/2017

Pharmacopoeias, as standard references for pharmaceutical drug specifications and reference standards in the form of monographs, play a pivotal role in assuring drug quality and safety. How such pharmacopoeias relate to non-biological complex drugs (NBCDs) was a subject discussed by Professor Gerrit Borchard in a GaBI Journal article [1].

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In vitro analysis of follow-on versions of sevelamer

Non‐Biological Complex Drugs/Research | Posted 18/11/2016

Authors from the US Food and Drug Administration (FDA) have published details of an evaluation of the in vitro efficacy of sevelamer hydrochloride and sevelamer carbonate [1]. The results from this analysis, say the authors, ‘will be useful in assisting with “in vivo” biowaiver for the approval of generic sevelamer drug products’.

Review committee V15a16

Determining the bioequivalence of follow-on iron formulations

Non‐Biological Complex Drugs/Reports | Posted 04/11/2016

Challenges associated with determining the bioequivalence of follow-on iron formulations as non-biological complex drugs (NBCDs) was a subject discussed at the US Food and Drug Administration’s Public Meeting, which was held in June 2016, as part of the agency’s FY 2016 Regulatory Science Initiatives.

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FDA to set up abbreviated pathway for complex products

Non‐Biological Complex Drugs/Polices & Legislation | Posted 21/10/2016

As part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization recently agreed with industry [1], the US Food and Drug Administration (FDA) has committed to setting up a new approval pathway for drugs with complex active ingredients and formulations, as well as for drug-device combinations.

Eyedrop Restatis V13H30

Challenges in the assessment of ophthalmic emulsions

Non‐Biological Complex Drugs/Reports | Posted 07/10/2016

Challenges in the assessment of the similarity or equivalence of ophthalmic emulsions as non-biological complex drugs (NBCDs) was a subject discussed at the US Food and Drug Administration’s (FDA) Public Meeting, which was held in June 2016, as part of the agency’s FY 2016 Regulatory Science Initiatives.

Nanoparticle V13J18

Cancer lab to evaluate bioequivalence of nanosimilars

Non‐Biological Complex Drugs/News | Posted 23/09/2016

The Frederick National Laboratory for Cancer Research (Frederick National Lab) announced on 10 June 2016 that it was collaborating with the US Food and Drug Administration (FDA) on the characterization of nanosimilars.

NBCD 2

A conference on ‘Equivalence of Complex Drug Products: Scientific and Regulatory Challenges’

Non‐Biological Complex Drugs/News | Posted 09/09/2016

A conference presented by the Non-Biological Complex Drugs Working Group (NBCD WG), the Nanotechnology Characterization Laboratory (NCL) of the Frederick National Lab for Cancer Research, and the New York Academy of Sciences on ‘the Equivalence of Complex Drug Products: Scientific and Regulatory Challenge’, Wednesday, 9 November 2016, from 8:30 am to 5:15 pm in New York, USA.