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, PhD; Sesha Neervannan, PhD; Professor Daan JA Crommelin, PhD Abstract: This paper discusses the group of non-biological complex drug (NBCD) products and presents the reasons why…

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), therapeutic equivalence

DOI: 10.5639/gabij.2015.0404.037

Abstract: Some years ago, Australian regulatory authorities decided to follow the path laid down by the European Medicines Agency in adopting a process for approval of biosimilars. This has been a largely successful process, resulting in the licensing of biosimilars for many peptides, especially epoetin and granulocyte colony-stimulating factor (G-CSF). Aside from the availability of…

Author(s): Professor David A Power, MD, PhD, FRCP, FRACP

Australia, biosimilars, pharmaceutical benefits scheme, TGA

DOI: 10.5639/gabij.2013.0203.030

Abstract:  A study presented at the 2010 Congress of the European Society of Cardiology, had created a considerable stir. Its abstract allegedly showed that the originator drug Lipitor was more beneficial than any of its generic statin equivalents. But, in fact the study merely showed that the different potencies of statins were not taken adequately…

Author(s): Christoph Baumgärtel, MD, MSc

cardiovascular risk, generics, inferiority, potency, statins

DOI: 10.5639/gabij.2012.0103-4.032

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 on the activities concerning non-biological complex drugs (NBCDs), the mechanisms by which new monographs are introduced into the European and the US pharmacopoeias are presented.…

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

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 drugs and the indiscriminate use of biosimilars. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharmacies concerning generic substitution. The guidelines…

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

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

DOI: 10.5639/gabij.2012.0102.021

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 and effective medicines thereby granting greater patient access to affordable health care. A sound scientific basis and a robust regulatory process to demonstrate bioequivalence of…

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

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 the marketing authorization function as the National Regulatory Authority (NRA). This paper provides an overview of the organization, regulatory expectations and current practices of the…

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

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 of biosimilars increases the need to understand the clinical impact of potential differences versus originator products. This paper reviews important recently published technical data on…

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

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; Andras Süle, PhD; Ad A van Bodegraven, MD, PhD; Rene Westhovens, MD, PhD; Jo De Cock Introduction/Objectives: This manuscript aims to provide guidance to policymakers with…

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

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 and analytics in establishing and confirming biosimilarity are discussed in this paper. Submitted: 28 July 2015; Revised: 15 August 2015; Accepted: 16 August 2015; Published…

Author(s): GaBI Journal Editor

analytics, biosimilarity, clinical studies, extrapolation

DOI: 10.5639/gabij.2015.0404.041

Author byline as per print journal: Professor Philip J Schneider1, MS, FASHP, FASPEN, FFIP; Michael S Reilly2, Esq Abstract: Approximately 25% of all new medicines approved in recent years and in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory and payer requirements, combined with the needs…

Author(s): Michael S Reilly, Esq, Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP

biologicals/biosimilars, competition, patients, procurement, substitution, sustainability

DOI: 10.5639/gabij.2020.0902.013

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 a follow-on product must be to be considered biosimilar. Sample sizes for clinical biosimilar trials using traditional designs often exceed 500 patients. Several publications have…

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