Articles

Commentary

Published on 24 March 2015

Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines

Abstract: The backlog in medicines registration in South Africa is a result of the implementation of pro-generics policies without strengthening the regulator to handle the substantial increase in registration applications...

Author(s): Allyson M Pollock, MBChB, FFPH, MRCP (Ed), MRCGP, Henry MJ Leng, PhD, David Sanders, MRCP

access to medicines, generic medicines registration, registration backlog, South Africa

DOI: 10.5639/gabij.2015.0402.014

21.077 views

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Editorial

Published on 04 December 2013

Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise?

Abstract: Despite the fact that hepatitis C is a disease of global importance, many countries cannot afford the costly but effective combination treatment of peg-interferon and ribavirin, which was recently...

Author(s): Armando A Genazzani, DPhil, MD, Nicola Magrini, MD

alternative therapeutic products, biosimilar, essential medicines list, peginterferon, regulatory approval pathways, WHO

DOI: 10.5639/gabij.2013.0204.044

20.816 views

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Perspective

Published on 11 January 2013

Biosimilarity in Latin America

Abstract: The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes...

Author(s): Chang Chiann, PhD, Leonardo de Souza Teixeira, PhD, Fabiana Fernandes de Santana e Silva Cardoso, MSc, Isabela da Costa César, PhD, Gerson Antônio Pianetti, PhD

biosimilarity, complex drugs, Latin America

DOI: 10.5639/gabij.2013.0202.021

20.710 views

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Special Report

Published on 12 December 2016

The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products

Abstract: European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic products have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such...

Author(s): Emmanuelle Charton, PhD

biotherapeutic products, complexity of biologicals, monographs, pharmacopoeia, public standards

DOI: 10.5639/gabij.2016.0504.045

20.148 views

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Regulatory

Published on 20 August 2012

PMDA update: the current situation and future directions

Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese drug regulatory agency, sharing responsibilities with the Ministry of Health, Labour and Welfare. Its mission is to protect the...

Author(s): Yuki Ando, BA, Toshiyoshi Tominaga, PhD, Tatsuya Kondo, MD, PhD

approval review, international strategy, Japanese regulatory authority, PMDA, regulatory science, safety measure

DOI: 10.5639/gabij.2013.0201.013

19.995 views

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Review Article

Published on 26 May 2020

Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Associate Professor Sia Ming Kian, BSc (Pharm) (Hons); Chan Lai Wah, BSc (Pharm) (Hons), PhD...

Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Sia Ming Kian, BSc (Pharm) (Hons)

ASEAN, biopharmaceutical manufacturing, biopharmaceuticals, good manufacturing practice, harmonization, regulatory guidelines

DOI: 10.5639/gabij.2020.0902.010

19.986 views

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Original Research

Published on 22 April 2013

Regional tenders on biosimilars in Italy: potentially competitive?

Author byline as per print journal: Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Roberta Lo Muto, MSc, Silvy Duranti, MBA, Professor Livio Garattini Introduction: Health care in Italy is...

Author(s): Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Professor Livio Garattini, Roberta Lo Muto, MSc, Silvy Duranti, MBA

biosimilars, competition, Italy, regions, tender

DOI: 10.5639/gabij.2013.0203.036

19.803 views

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Review Article

Published on 24 March 2014

Tyrosine kinase inhibitors becoming generic drugs – risks and chances from a regulatory perspective

Author byline as per print journal: Niels Eckstein, PhD; Lea Röper, BSc; Bodo Haas, PhD; Henrike Potthast, PhD; Ulrike Hermes, PhD; Christoph Unkrig, MD; Frauke Naumann-Winter, PhD; Harald Enzmann, MD Aim: To provide a systematic overview on: i)...

Author(s): Bodo Haas, PhD, Christoph Unkrig, MD, Frauke Naumann-Winter, PhD, Harald Enzmann, MD, Henrike Potthast, PhD, Lea Röper, BSc, Niels Eckstein, PhD, Ulrike Hermes, PhD

generics, narrow therapeutic index drugs (NTDI), orphan drug status, product-specific bioequivalence guidance, tyrosine kinase inhibitors (TKI)

DOI: 10.5639/gabij.2014.0302.021

19.048 views

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Perspective

Published on 28 May 2015

Norway, biosimilars in different funding systems. What works?

Abstract: Biosimilars can substitute treatment with expensive biological drugs and release money to treat more patients. Experience from Norway shows how this can be done with and without success. Submitted:...

Author(s): Asbjørn Mack, MD

biosimilars, discounts, market penetration, tender

DOI: 10.5639/gabij.2015.0402.018

18.776 views

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Review Article

Published on 22 August 2016

Current state of subsequent entry biologics (biosimilars) in Canada: a view from regulatory, reimbursement, clinician, and patient perspectives

Abstract: Biological molecules represent a significant portion of therapies utilized in Canada. Biosimilars, also known as subsequent entry biologics (SEBs) in Canada, are highly comparable versions of the originator products....

Author(s): Eric CK Siu, MSc, PhD, George Wyatt, BSc, MBA

biosimilars, CADTH, Canada, CDR, pCODR, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0503.028

18.538 views

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