Abstract: Regulations for biosimilars in the Republic of Korea have been in place since 2009. Since then, the country has also put in place specific guidelines and approved four biosimilars. Submitted: 18 December 2014; Revised: 23 February 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 The legislative basis for the regulation of…

Author(s): Jeewon Joung, PhD

biosimilar, guidelines, regulation, Republic of Korea

DOI: 10.5639/gabij.2015.0402.019

Abstract: Clinical safety is important during the development of a biosimilar. This paper provides an overview of the main aspects related to the safety assessment of biosimilars. The European Medicines Agency’s ‘Guideline for similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues’, which is currently under revision, forms the basis…

Author(s): Christian K Schneider, MD, Thijs J Giezen, PharmD, PhD, MSc

biosimilar, clinical safety, immunogenicity, pharmacovigilance

DOI: 10.5639/gabij.2014.0304.041

Introduction: Similar biotherapeutic products (SBPs or biosimilars) include a rapidly expanding number of therapeutic products worldwide. However, agreement about the best practices for their regulation are lacking in many countries including in the Middle East and North Africa (MENA). Methods: The first MENA educational workshop on SBPs was held in Dubai, UAE on 1 September…

Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath

biologicals, biosimilars, follow-on drugs, MENA (Middle East and North Africa), regulatory practice

DOI: 10.5639/gabij.2015.0404.039

Abstract: Generic medicines are promoted in many countries as an essential part of the healthcare system. However, in Yemen, there are many challenges to the utilisation of generic medicines. Currently, there is no national level policy to enhance or promote generic medicines use. In addition, other challenges to the use of generic medicines in Yemen…

Author(s): Saleh Karamah AL-Tamimi, BPharm, MPharm (ClinPharm), Mohamed Azmi Ahmad Hassali, PhD, Alian A Alrasheedy, BPharm(Hons), MPharm(Clin), BCPS

challenges, consumers, generic medicines, healthcare professionals, Yemen

DOI: 10.5639/gabij.2013.0202.017

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract: The importance of monoclonal antibodies as a product class and the challenge of assessing unwanted immunogenicity for these products have prompted the drafting of a new CHMP (Committee for Medicinal Products for Human Use) guideline. The ‘Guideline on immunogenicity assessment of…

Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath

biosimilar, comparability, quality, risk, safety

DOI: 10.5639/gabij.2013.0201.007

Abstract: Two biosimilar TNF-alfa monoclonal antibody (mAb) products were approved for clinical use in the European Union on 10 September 2013, following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in July 2013. The products, with trade names Remsima and Inflectra (INNs infliximab) contain an identical mAb. This approval shows…

Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath

biosimilar, EPAR, infliximab, monoclonal antibodies

DOI: 10.5639/gabij.2014.0301.004

Author byline as per print journal: Assistant Professor Gianluca Trifirò, MD, PhD; Ylenia Ingrasciotta, MSc; Ilaria Marcianò, MSc; Armando A Genazzani, DPhil, MD Abstract: This paper aims to provide an overview of the available real-world data about the pattern of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy. Different observational studies…

Author(s): Armando A Genazzani, DPhil, MD, Assistant Professor Gianluca Trifirò, MD, PhD, Ilaria Marcianò, MSc, Ylenia Ingrasciotta, MSc

biosimilars, comparative effectiveness, healthcare administrative databases, real world data, switching

DOI: 10.5639/gabij.2017.0603.023

Submitted: 24 May 2016; Revised: 8 June 2016; Accepted: 10 June 2016; Published online first: 24 June 2016 CT-P13, also known by its brand names Remsima or Inflectra, is a biosimilar of the infliximab reference product (RP) Remicade. CT-P13 is approved in Europe, the US and elsewhere for use in all indications for which the…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.023

Abstract: The Editor-in-Chief expresses his concerns about the proposal of a WHO run system to approve copy biologicals in the Milani and Gaspani paper [1]. The paper by Milani and Gaspani [1] suggests that the World Health Organization (WHO) sets up a programme to approve follow-on pegylated interferons and similar biological medications, that is biological…

Author(s): Professor Philip D Walson, MD

biological products, pegylated interferons, World Health Organization (WHO)

DOI: 10.5639/gabij.2013.0204.043

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, have existed in India until recently. This has been the case despite the fact that the requirements for granting regulatory…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0201.006

Author byline as per print journal: Professor Pere Gascón, MD; Ruediger Jankowsky, PhD; Karsten Roth, PhD Abstract: Cinfa Biotech, the biosimilars specialists of the Cinfa Group, reviewed pegfilgrastim biosimilar approaches to treat chemotherapy-induced neutropenia. Professor Dr Gascón discussed ’perspectives of pegfilgrastim’ and Dr Roth and Dr Jankowsky discussed why biosimilars are vital for oncology care. Submitted:…

Author(s): Karsten Roth, PhD, Professor Pere Gascón, MD, Ruediger Jankowsky, PhD

biosimilars, biotech, G-CSF, neutropenia, pegfilgrastim

DOI: 10.5639/gabij.2017.0604.040

Abstract: The first recognized and trusted generic drugs were launched in France in 1995, at the same time that the Prime Minister Alain Juppé introduced his new plan on Retirement and Social Security. It has taken 20 years for generic drugs to become integrated into the pharmacy community, and for acceptance to be reached by…

Author(s): Jacques Rottembourg, MD, Jessica Nasica-Labouze, PhD

biosimilars, generic drug repertory, generics, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2015.0403.029