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

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 Introduction: There are concerns over the quality of generic medicines in Pakistan. This is due to perceived non-compliance with good manufacturing practice (GMP), whereby the…

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

Abstract: High resolution analytical techniques reveal structural micro-heterogeneity within endogenous proteins, however, they are ‘seen’ as ‘self’ molecules by the immune system and immunological tolerance is established. In contrast the protein biotherapeutics are produced in non-human cells and multiple downstream protocols are employed in the isolation and purification of drug product; consequent micro-heterogeneities may be…

Author(s): Professor Roy Jefferis, PhD, DSc, MRCP, FRCPath

allotypes, erythropoietin, human IgG, idiotypes, immunogenicity, polymorphisms, post-translational modifications, structural heterogeneity

DOI: 10.5639/gabij.2018.0702.013

Author byline as per print journal: Vito Annese, MD, PhD; Cristina Avendaño-Solá, MD, PhD; Professor Ferdinand Breedveld, MD; Niklas Ekman, PhD; Thijs J Giezen, MSc, PharmD, PhD; Professor Fernando Gomollón, MD, PhD; Research Professor Pekka Kurki, MD, PhD; Professor Tore Kristian Kvien, MD; Professor Andrea Laslop, MD; Professor Lluís Puig, MD, PhD; Robin Thorpe, PhD, FRCPath;…

Author(s): Adjunct Professor Pekka Kurki, MD, PhD, Cristina Avendaño-Solá, MD, PhD, Elena Wolff-Holz, MD, Martina Weise, MD, Niklas Ekman, PhD, Professor Andrea Laslop, MD, Professor Ferdinand Breedveld, MD, PhD, Professor Fernando Gomollón, MD, PhD, Professor Lluís Puig, MD, PhD, Professor Tore Kristian Kvien, MD, Robin Thorpe, PhD, FRCPath, Thijs J Giezen, PharmD, PhD, MSc, Vito Annese, MD

biologicals/biosimilars, extrapolation, interchangeability, medical societies, prescribers, regulators

DOI: 10.5639/gabij.2016.0502.019

Abstract: The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar development. However, the information-driven stepwise approach encouraged by this pathway leading to approval of biosimilar products is only reflected in a single section of the product labelling…

Author(s): European Biopharmaceutical Enterprises

biosimilars, EMA (European Medicines Agency), labels, PIL (product information leaflet), Summary of Product Characteristics (SmPC)

DOI: 10.5639/gabij.2014.0304.043

Author byline as per print journal: Thijs J Giezen, PharmD, PhD; Sabine MJM Straus, MD, PhD Abstract:  Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small molecule drugs as well as biologicals, as the full safety profile can only be known after they have been placed on the market. Biologicals have…

Author(s): Sabine MJM Straus, MD, PhD, Thijs J Giezen, PharmD, PhD, MSc

biologicals, biosimilars, immunogenicity, pharmacovigilance, traceability

DOI: 10.5639/gabij.2012.0103-4.033

Author byline as per print journal: Jolita Seckute1, PhD; Ingrid Castellanos2, PhD; Steven Bane1, PhD Study Objectives: To evaluate extended in-use stability of bevacizumab biosimilar, ABP 215, after dilution into intravenous bags, extended storage, and simulated infusion to enable advanced preparation and storage. Methods: Two lots of ABP 215 were diluted to high- (16.5 mg/mL)…

ABP 215, administration, bevacizumab, biosimilar, infusion, stability

DOI: 10.5639/gabij.2020.0904.026

Author byline as per print journal: Wenjie Zeng, BSc, PhD; Houmei Xi, B Eng; Brian Godman, BSc, PhD; Alexander E Finlayson, MD, MRCP;  Rickard E Malmstrom, MD, PhD Introduction: Pharmaceutical expenditure rose by 16% per annum in China during the past decade, and now represents 46% of total healthcare expenditure. Initiatives to moderate growth include pricing…

Author(s): Alexander E Finlayson, MD, MRCP, Brian Godman, BSc, PhD, Houmei Xi, B Eng, Rickard E Malmstrom, MD, PhD, Wenjie Zeng, BSc, PhD

China, drug utilization study, generics, health policies, pharmaceuticals, statins

DOI: 10.5639/gabij.2014.0303.030

Abstract: The AIFA’s position paper recognizes the relevance of biosimilars to ensure the sustainability of drug expenditure but the new price and reimbursement procedure may not favour their prompt market access. Submitted: 26 June 2013; Revised: 10 July 2013; Accepted: 11 July 2013; Published online first: 24 July 2013 In the final position paper on…

Author(s): Gianluigi Casadei, MD

AIFA, biosimilars, market access, position paper, pricing, reimbursement

DOI: 10.5639/gabij.2013.0203.033

Author byline as per print journal: G Castañeda-Hernández, PhD; L Carbajal-Rodríguez, MD; M Cerón-Rodríguez, MD; Professor LC Correa-González, MD; A Esquivel-Aguilar, PhD; SJ Franco-Ornelas, MD; JE García Ortiz, PhD; CM Hernández-Guadarrama, MD; JI Navarrete-Martínez, MD; Y Santillán-Hernández, MD; E Terreros-Muñoz, MD Abstract: Enzyme replacement therapy (ERT) is the first-line treatment for Gaucher disease (GD). The…

Author(s): A Esquivel-Aguilar, PhD, CM Hernández-Guadarrama, MD, E Terreros-Muñoz, MD, G Castañeda-Hernández, JE García Ortiz, PhD, JI Navarrete-Martínez, MD, L Carbajal-Rodríguez, MD, M Cerón-Rodríguez, MD, Professor LC Correa-González, MD, SJ Franco-Ornelas, MD, Y Santillán-Hernández

biosimilar, Gaucher disease, imiglucerase, non-originator imiglucerase, orphan drugs

DOI: 10.5639/gabij.2019.0802.008

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

Abstract: With the advent of complex therapies in the form of biologicals, emerging biosimilars and non-biological complex drugs, monitoring for treatment related benefit and the potential for adverse effects is as critical as monitoring for signs and symptoms of rheumatoid arthritis disease progression. With a focus on strengthening patient and provider education and engagement, patients…

Author(s): Janet S Wyatt, RN, PhD, FAANP

biological therapy, patient engagement, pharmacovigilance, treatment response

DOI: 10.5639/gabij.2014.0301.008