Non‐Biological Complex Drugs

FDA issues final guidance on liposome drug products

Non‐Biological Complex Drugs/Guidelines | Posted 27/04/2018

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance document for non-biological complex drugs (NBCDs). The finalized guidance covers what applicants should submit for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for liposome products.

FDA approves 40 mg follow-on version of glatiramer acetate

Non‐Biological Complex Drugs/News | Posted 09/03/2018

Sandoz, the generics division of Novartis, announced on 13 February 2018 the approval of its 40 mg follow-on version of glatiramer acetate by the US Food and Drug Administration (FDA).

Mylan launches first follow-on glatiramer acetate in the UK

Non‐Biological Complex Drugs/News | Posted 15/02/2018

US generics giant Mylan announced on 23 January 2018 that it had launched Brabio, the first follow-on version of Teva Pharmaceutical’s (Teva) Copaxone (glatiramer acetate) in the UK.

Biosimilars and follow-on NBCDs for MS in Europe, the US and Canada

Non‐Biological Complex Drugs/Research | Posted 19/01/2018

The advent of biological medicines has significantly transformed the landscapes of many disease spaces and improved the lives of millions around the world. However, the structural complexity and sensitivity of such products result in a high price tag, adding to already financially strained healthcare systems. As these and other expensive complex drugs lose market exclusivity, stakeholders eagerly await the arrival of lower cost alternatives, such as biosimilars and follow-on non-biological complex drugs (NBCDs). Nevertheless, stakeholders remain uncertain about key issues which have resulted in heterogeneous reimbursement policies and varying levels of biosimilar uptake and differences in the approval processes for follow-on NBCDs between different markets.

Impax announces FDA approval of follow-on sevelamer carbonate

Non‐Biological Complex Drugs/News | Posted 17/11/2017

US generics maker Impax Laboratories (Impax) announced on 23 October 2017 that it had received final US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) for a follow-on version of Renvela (sevelamer carbonate).

FDA approves follow-on version of sevelamer

Non‐Biological Complex Drugs/News | Posted 30/06/2017

Indian generics maker Aurobindo Pharma (Aurobindo) announced on 15 June 2017 that it had received US Food and Drug Administration (FDA) approval for its follow-on version of sevelamer.

Challenges in the regulation of NBCDs

Non‐Biological Complex Drugs/Research | Posted 12/05/2017

Author Leonie Hussaarts and colleagues discuss in a white paper the regulatory frameworks in use worldwide to approve non-biological complex drugs (NBCDs) and their follow-on versions [1].

Scientific and regulatory considerations for follow-on versions of complex drug products containing nanomaterials

Non‐Biological Complex Drugs/Research | Posted 05/05/2017

In this article [1], US Food and Drug Administration (FDA) scientists give a comprehensive overview of the nanomaterials presently available in the US and the challenges encountered when considering approval of generic (or follow-on) versions of these often complex drug products. More specifically, these challenges encompass ‘establishing active ingredient sameness, equivalence in the drug product physicochemical properties and equivalence in thein vivodrug exposure profiles between innovator and generic drug products’.

Equivalence of complex drug products

Non‐Biological Complex Drugs/Reports | Posted 14/04/2017

Complex drug products and their generic (or follow-on) versions was the subject discussed at the New York Academy of Sciences symposium on Equivalence of Complex Drug Products: Scientific and Regulatory Challenges [1].

Follow-up studies needed to ensure safety for follow-on NBCDs

Non‐Biological Complex Drugs/Research | Posted 31/03/2017

Product-specific testing to determine therapeutic equivalence has been an approach used by the US Food and Drug Administration (FDA) since 1984, including products with unique features. In a recent paper Kesselheim and Gagne [1] discussed a number of aspects related to NBCDs.

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.

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].

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.

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].

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’.

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.

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.

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.

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.

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.

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