Articles

Regulatory

Published on 26 May 2020

Pelmeg®, a biosimilar pegfilgrastim developed in the context of evolving regulatory guidelines

Author byline as per print journal: Karsten Roth, PhD; Hendrik Wessels, PhD; Josef Höfler, PhD; Ulrike Scholz, PhD; Dirk Lehnick, PhD Abstract: Pelmeg® is a biosimilar pegfilgrastim, which obtained European...

Author(s): Dirk Lehnick, PhD, Hendrik Wessels, PhD, Josef Höfler, PhD, Karsten Roth, PhD, Ulrike Scholz, PhD

biosimilar, filgrastim, Neulasta®, pegfilgrastim, Pelmeg®, targeted development

DOI: 10.5639/gabij.2020.0903.021

18.327 views

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Guidelines

Published on 05 March 2012

Generics substitution in primary care: summary of the Dutch community pharmacies guidelines

Abstract:  Marketed medicines that have passed bioequivalence testing should in general be substitutable. However, for a variety of reasons, caution may be warranted, particularly with regard to narrow therapeutic index...

Author(s): Leonora Grandia, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP

biologicals, biosimilars, Dutch guidelines, generics substitution, interchangeability, narrow therapeutic index

DOI: 10.5639/gabij.2012.0102.021

18.083 views

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Perspective

Published on 23 September 2015

Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Stefan Mühlebach, PhD; Vinod P Shah, PhD; Scott E McNeil, PhD; Professor Gerrit Borchard, PharmD, PhD; Vera Weinstein, PhD; Beat Flühmann,...

Author(s): Beat Flühmann, PhD, Daan JA Crommelin, Jon SB de Vlieger, PhD, Professor Gerrit Borchard, PharmD, PhD, Professor Stefan Mühlebach, PhD, Scott E McNeil, Sesha Neervannan, PhD, Vera Weinstein, PhD, Vinod P Shah, PhD

glatiramoids, iron-carbohydrate complexes, liposomes, nanomedicines, non-biological complex drug (NBCD) products, therapeutic equivalence

DOI: 10.5639/gabij.2015.0404.037

18.049 views

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Special Report

Published on 07 April 2016

Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias

Abstract: Pharmacopoeias, as standard references for pharmaceutical drug specifi cations and reference standards in the form of monographs, play a pivotal role to assure drug quality and safety. With emphasis...

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

drug quality, ICH, non-biological complex drug (NBCD), Ph. Eur., pharmacopoeia, USP

DOI: 10.5639/gabij.2016.0501.009

18.029 views

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Review Article

Published on 23 January 2017

Ocular emulsions and dry eye: a case study of a non-biological complex drug product delivered to a complex organ to treat a complex disease

Author byline as per print journal: Anu Gore, PhD; Mayssa Attar, PhD; Chetan Pujara, PhD; Sesha Neervannan, PhD Abstract: Generic drugs are intended to provide a lower cost option of safe...

Author(s): Anu Gore, PhD, Chetan Pujara, PhD, Mayssa Attar, PhD, Sesha Neervannan, PhD

dry eye, ocular, ophthalmic, safety, topical

DOI: 10.5639/gabij.2017.0601.004

17.684 views

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Perspective

Published on 20 January 2014

How to realize the potential of off-patent biologicals and biosimilars in Europe? Guidance to policymakers

Author byline as per print journal: Steven Simoens, PhD; Claude Le Pen, PhD; Niels Boone, PharmD; Ferdinand Breedveld, MD, PhD; Antonella Celano; Antonio Llombart-Cussac, MD, PhD; Frank Jorgensen, MPharm, MM;...

Author(s): Ad A van Bodegraven, MD, PhD, Andras Süle, PhD, Antonella Celano, Antonio Llombart Cussac, MD, PhD, Frank Jorgensen, MPharm, MM, Jo De Cock, Niels Boone, PharmD, Professor Claude Le Pen, PhD, Professor Ferdinand Breedveld, MD, PhD, Rene Westhovens, MD, PhD, Steven Simoens, MSc, PhD

biologicals, biosimilars, competition, Europe, policy, sustainability

DOI: 10.5639/gabij.2018.0702.014

17.630 views

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Regulatory

Published on 23 September 2014

Regulation of biologicals in Malaysia

Abstract: The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises...

Author(s): Arpah Abas, BPharm, Yvonne Siew Khoon Khoo, BPharm (Hons) MMedSc, PhD (Pharmacology)

biologicals, evaluation, Malaysia, National Pharmaceutical Control Bureau (NPCB), regulation

DOI: 10.5639/gabij.2014.0304.044

17.454 views

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Perspective

Published on 29 June 2016

Importance of manufacturing consistency of the glycosylated monoclonal antibody adalimumab (Humira®) and potential impact on the clinical use of biosimilars

Author byline as per print journal: Professor Paul J Declerck, PhD; Paul W Tebbey, PhD Abstract: The clinical performance of biological therapies is affected by their manufacturing processes. The advent...

Author(s): Paul W Tebbey, PhD, Professor Paul J Declerck, PhD

adalimumab, biosimilar pharmaceuticals, consistency, glycosylation, immunogenicity, manufacturing

DOI: 10.5639/gabij.2016.0502.018

17.416 views

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Special Report

Published on 11 December 2015

Supporting biosimilarity and extrapolation

Abstract: With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies...

Author(s): GaBI Journal Editor

analytics, biosimilarity, clinical studies, extrapolation

DOI: 10.5639/gabij.2015.0404.041

17.311 views

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Original Research

Published on 16 December 2013

Alternative statistical strategies for biosimilar drug development

Introduction: Many regulatory authorities have published requirements for the approval of biosimilar medicinal products. However, there is no guidance on which quantitative standards should be used to define how similar...

Author(s): Austin J Combest, PharmD, MBA, Song Wang, PhD, Brian T Healey, PharmD, MS, MBA, RAC, Dirk J Reitsma, MD

Bayesian design, biosimilar, drug development, repeated measures analysis, statistics strategy

DOI: 10.5639/gabij.2014.0301.006

17.140 views

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Original Research

Published on 27 July 2016

Assessment of active pharmaceutical ingredients in drug registration procedures in Pakistan: implications for the future

Author byline as per print journal: Babar Khan, BPharm, MPH, PhD; Brian Godman, BSc, PhD; Ayesha Babar, BPharm, MPhil; Shahzad Hussain, BPharm, MPhil; Sidra Mahmood, PharmD, MSc; Tahir Aqeel, BPharm, MPhil...

Author(s): Ayesha Babar, BPharm, MPhil, Babar Khan, BPharm, MPH, PhD, Brian Godman, BSc, PhD, Shahzad Hussain, BPharm, MPhil, Sidra Mahmood, PharmD, MSc, Tahir Aqeel, BPharm, MPhil

API (active pharmaceutical ingredient), Drugs Regulatory Authority, generics, ibuprofen, Pakistan

DOI: 10.5639/gabij.2016.0504.041

17.081 views

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