Abstract: Although not derived from living sources, non-biological complex drug (NBCD) products have the immunogenicity and molecular complexity of biological drugs. NBCDs typically contain heterogenous mixtures of closely related nanoparticulate components that cannot be isolated, quantified, or entirely characterized physicochemically. Development of follow-on versions of NBCDs poses many of the same scientific challenges associated with…

Author(s): J Michael Nicholas, PhD

follow-on drugs, glatiramoids, iron-carbohydrate complexes, liposomes, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2014.0302.020

Introduction: A survey of the views of European physicians on familiarity of biosimilar medicines has demonstrated the need for distinguishable non-proprietary names to be given to all biologicals. Methods: The Alliance for Safe Biologic Medicines recruited 470 prescribers with clinical experience of biologicals in France, Germany, Italy, Spain and the UK to answer questions relating…

Author(s): Michael S Reilly, Esq, Richard O Dolinar, MD

biological, biosimilar, Europe, INN, pharmacy substitution, prescribers

DOI: 10.5639/gabij.2014.0302.018

Introduction: The healthcare sector is one of the most rapidly expanding and dynamic industries in the world. Pharmaceutical expenditure is now growing faster than other components of healthcare overheads. Globally, pressures to manage pharmaceutical spending have led to increased prescribing of generic drugs. Use of generic drugs in private medical centres in Malaysia, however, remains…

Author(s): Muhamad Ali SK Abdul Kader, MD, Rohit Kumar, MPharm, Mohamed Azmi Ahmad Hassali, PhD, Navneet Kaur, PhD

generics, Malaysia, perceptions, pharmaceuticals, private hospitals

DOI: 10.5639/gabij.2014.0302.019

Submitted: 2 March 2014; Revised: 7 March 2014; Accepted: 8 March 2014; Published online first: 21 March 2014 The guideline ‘Note for guidance on modified release oral and transdermal dosage forms: Section II (Pharmacokinetic and clinical evaluation)’ [1] was issued over 10 years ago, and the need for revision was recognized in 2010. An international…

Author(s): Christoph Baumgärtel, MD, MSc, Jan Neuhauser, MD

DOI: 10.5639/gabij.2014.0302.024

Abstract: ‘Non-binding recommendations’ from regulatory bodies are in place for evaluation and production of generic liposomal doxorubicin injection. However, how these nano-sized generics (‘nanosimilars’) should be characterized and evaluated, and particularly when the ‘reference listed product’ is no longer in production are among the major issues. We discuss these issues with respect to complexity of…

Author(s): Professor S Moein Moghimi, PhD, Z Shadi Farhangrazi, PhD

adverse reactions, complement system, immunogenicity, liposomes, nanoparticle size, vesicle morphology

DOI: 10.5639/gabij.2014.0302.017

Abstract: The pharmacological activity and toxicity of non-biological complex drugs (NBCDs) depends on their complex structure and composition. The regulatory approach leading to the registration of such drugs and their follow-on products, deemed ‘nanosimilars’, must be based on emerging scientific knowledge of NBCD properties determining their in vivo fate. Submitted: 8 April 2014; Revised: 11…

Author(s): Professor Gerrit Borchard, PharmD, PhD

nanomedicines, nanosimilars, non-biological complex drug (NBCD), regulatory

DOI: 10.5639/gabij.2014.0302.016

Editor's Letter

Published on 11 June 2014

What to look forward to in GaBI Journal, 2014, Issue 2

As mentioned previously, non-biological complex drugs (NBCDs) continue to raise important regulatory and practice issues. This issue of the GaBI Journal contains a number of manuscripts dealing with these products and begins with an update on NCBDs (nanosimilars) developments by Professor Gerrit Borchard. This is followed by a manuscript discussing the use of size and…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0302.015

Author byline as per print journal: Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD, Beat Flühmann, PhD Introduction: In recent years a new category of medicinal products, the non-biological complex drugs (NBCDs) emerged. They are distinct from both the small molecules and the biological therapeutics by being composed of non-homomolecular large structures, some of…

Author(s): Beat Flühmann, PhD, Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD

follow-on drugs, nanomedicines, non-biological complex drug (NBCD), regulatory practice

DOI: 10.5639/gabij.2014.0301.010

Abstract: In this paper, we provide an overview of a PhD project we undertook on European policy on generic medicines. In the course of our research, we identified various causes for delayed market access of generic medicines and the need for policies to accelerate market access. These should work in conjunction with policies designed to…

Author(s): Pieter Dylst, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP, Steven Simoens, MSc, PhD

demand-side policies, Europe, European policy, generic medicines, supply-side policies

DOI: 10.5639/gabij.2014.0301.011

The European Medicines Agency recommends the use of pharmacodynamics (PD) markers when establishing biosimilarity, but no such biomarkers are known for the clinical efficacy of bevacizumab (Avastin). For this reason, confirmatory clinical efficacy studies are essential, write Hans Ebbers et al. of Utrecht University in The Netherlands [1]. The biosimilar monoclonal antibodies (mAb) guideline released…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0301.013

Abstract: For harmonization of the authorization requirements for specific generic applications within the EU, consistent criteria were drafted for 16 active substances, which are out now for public consultation. Submitted: 2 January 2014; Revised: 6 January 2014; Accepted: 7 January 2014; Published online first: 20 January 2014 Official draft guidance has recently become available for…

Author(s): Christoph Baumgärtel, MD, MSc

authorization, bioequivalence, generics, product-specific bioequivalence guidance

DOI: 10.5639/gabij.2014.0301.009

Abstract: This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the need for harmonization of global regulatory standards for the approval of biosimilars. Biosimilars are recognized around the world as safe and effective medicines. Despite this…

Author(s): GaBI Journal Editor

biosimilars, Canada, EU, guidelines, Japan, Korea, regulation, World Health Organization (WHO)

DOI: 10.5639/gabij.2014.0401.012