Abstract: Biological and biotechnological medicines are important pharmaceutical innovations due to their influence on the treatment of many conditions and because they have led the way in devising new and innovative pharmacological therapies. In addition, biosimilars, which can be authorized on the date of expiry of a biological originator’s patent, give an opportunity for the…

Author(s): Enrico Adriano Raffaelli, LLB, JD, Fausto Massimino, LLB, JD

advertising, biosimilars, competition, Italy, public tenders, scientific information

DOI: 10.5639/gabij.2019.0801.002

Abstract: Representatives from Amgen and Actavis have spoken to GaBI (Generics and Biosimilars Initiative) about biosimilars. Topics covered included the clinical development of biosimilars, the need for further education, how the partnership model between the companies was working, the commercialization of biosimilars and their views on non-proprietary names for biosimilars Biotech giant Amgen and generics…

Author(s): GaBI Journal Editor

biosimilar, clinical development, commercializaiton, INN

DOI: 10.5639/gabij.2014.0303.035

Author byline as per print journal: Valderilio Feijó Azevedo, MD, PhD; Eduardo Mysler, MD; Alexis Aceituno Álvarez, PharmD, PhD; Juana Hughes, MSc; Francisco Javier Flores-Murrieta, PhD, FCP; Eva Maria Ruiz de Castilla, MS, MAA, PhD Abstract: With the emergence of biosimilars as a new class of biotherapeutic agents, the use of these products in Latin America has become a focus…

Author(s): Alexis Aceituno Álvarez, PharmD, PhD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Eduardo Mysler, MD, Eva Maria Ruiz de Castilla, MS, MAA, PhD, Francisco Javier Flores-Murrieta, PhD, FCP, Juana Hughes, MSc

biological products, biosimilarity, biosimilars, Latin America, reference biotherapeutic product (RBP), regulatory pathways

DOI: 10.5639/gabij.2014.0303.032

Author byline as per print journal: Robert Janknegt, PharmD, PhD, Niels Boone, PharmD, Frans Erdkamp, MD, PhD, Victor Zambon, MD Abstract: This manuscript describes the System of Objectified Judgement Analysis (SOJA) method applied to gonadotropin-releasing hormone (GnRH) agonists and antagonists in prostate cancer. The following selection criteria were used: efficacy, safety, tolerability, dosage frequency, user-friendly…

Author(s): Frans Erdkamp, MD, PhD, Niels Boone, PharmD, Robert Janknegt, PharmD, PhD, Victor Zambon, MD

drug selection, GnRH (gonadotropin-releasing hormone) agonists, GnRH antagonists, goserelin, leuprorelin, prostate cancer, SOJA (System of Objectified Judgement Analysis) method

DOI: 10.5639/gabij.2014.0303.031

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

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

Abstract: The arrival of biosimilars has led to considerable debate on how they can be used in clinical practice. A particular concern is related to the question of whether a biosimilar can be safely interchanged with the originator product or other biosimilars. Here we will discuss challenges to the regulatory approach for establishing interchangeability, in…

Author(s): Hans C Ebbers, PhD, Paul Chamberlain, BSc

biosimilars, immunogenicity, interchangeability, monoclonal antibodies, substitution, switching

DOI: 10.5639/gabij.2014.0302.022

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

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

It is far from clear whether off-patent biological medicines can offer the same cost savings as those offered by off-patent non-biological (chemically derived) medicines, write a group of Brussels-based health economists in the European Journal of Health Economics. Several key factors will play a role in realizing the potential of these effective low-cost agents, including…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0302.025

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) safety profiles; ii) pharmacokinetic parameters; and iii) regulatory framework of anti-cancer tyrosine kinase inhibitors (TKI). Methodology: Recherché of pharmakokinetic (PK)-parameter: i) Germany’s federal drug database…

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, orphan drugs, product-specific bioequivalence guidance, tyrosine kinase inhibitors (TKI)

DOI: 10.5639/gabij.2014.0302.021