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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.

Nanoparticle V13J18

Collaboration to introduce nanotechnologies in early stage drug development

Non‐Biological Complex Drugs/News | Posted 26/08/2016

The Frederick National Laboratory for Cancer Research (Frederick National Lab) announced on 10 June 2016 that it was collaborating with several major pharmaceutical companies. The collaboration aims to help them adopt nanotechnologies in early stage drug development, which, says the lab, is when the approach is most efficient and cost-effective.

NBCD ASEAN V16F09BF S61 V16F20JM

Iron carbohydrate follow-on NBCDs

Non‐Biological Complex Drugs/Reports | Posted 12/08/2016

Follow-on versions of iron–carbohydrate non-biological complex drugs (NBCDs) was a subject discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27-28 October 2014 [1].

Regulation-V13H16

Rigorous approach used to approve a follow-on version of glatiramer acetate

Non‐Biological Complex Drugs/Research | Posted 29/07/2016

Despite the difficulties associated with evaluating follow-on versions of non-biological complex drugs (NBCDs), the rigorous approach used by the US Food and Drug Administration (FDA) was able to establish the sameness of a follow-on glatiramer acetate (Glatopa) compared to Copaxone, according to researchers from Momenta Pharmaceuticals, the Northwestern University Feinberg School of Medicine and Kantor Neurology [1].

NBCD 1 V13J25

US guidelines for follow-on NBCDs

Non‐Biological Complex Drugs/Guidelines | 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).

NBCD 2

Non-biological complex drugs and their follow-on versions

Non‐Biological Complex Drugs/Research | Posted 03/06/2016

Since the first publication on non-biological complex drugs (NBCDs) appeared in 2011 this class of drug products has attracted growing interest and has resulted in the establishment of an Editorial Section on NBCDs in both the GaBI Journal and GaBI Online[1].

NBCD 2

Is a new pathway for NBCDs on the way in the US?

Non‐Biological Complex Drugs/Polices & Legislation | Posted 27/05/2016

The US Food and Drug Administration (FDA) does not formerly recognize non-biological complex drugs (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 [1].

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Follow-on glatiramer acetate gains European approval

Non‐Biological Complex Drugs/News | Posted 13/05/2016

Netherlands-based biologicals company Synthon announced on 12 April 2016 that it had successfully concluded the decentralized procedures for its follow-on glatiramer acetate product.

Guidance V13F21

FDA includes follow-on versions in its new cyclosporine guideline

Non‐Biological Complex Drugs/Guidelines | Posted 29/04/2016

In February 2016, the US Food and Drug Administration (FDA) issued a new draft guidance document for non-biological complex drugs (NBCDs). The new draft guidance on cyclosporine drug products replaces draft guidance published in March 2015.

Real Fake V13F14

Switching between originator and follow-on iron-sucrose

Non‐Biological Complex Drugs/Research | Posted 22/04/2016

Researchers from France describe and compare the haematological parameters and anaemia medications used in chronic kidney disease (CKD) patients undergoing haemodialysis, before and after switching between the iron-sucrose originator and an iron-sucrose follow-on version [1].

Haemodialysis V15a16 2

Follow-on intravenous iron formulations in haemodialysis patients

Non‐Biological Complex Drugs/Research | Posted 01/04/2016

A study into the efficiency of follow-on intravenous (IV) iron formulations compared to originator formulations in haemodialysis patients has shown the follow-on products to be less efficient at maintaining the same haemoglobin levels [1].