Editorial
Response to the Opinion entitled ‘Biosimilars drug development: time for a paradigm shift?’
Abstract: The Opinion published in this issue of GaBI Journal titled ‘Biosimilars drug development: time for a paradigm shift?’ by Sandeep N Athalye, Shivani Mittra and Ankitkumar M Ranpur proposes… Read More »
Is the local tolerance of injectable biosimilars too underestimated?
Author(s): Professor Alain Astier, PharmD, PhD
Page: 149
Abstract: This editorial highlights the importance of carrying out comparative studies of patient tolerance to biosimilars and originator products. Minor side effects can affect their acceptability. Submitted: 23 September 2020;… Read More »
Nomenclature for biosimilars; a continuing thorny issue
Abstract: Nomenclature for biosimilars is a controversial issue. In this issue of GaBI Journal, a paper by Sarshad et al. considers the US FDA’s published system for this and concludes… Read More »
Trends and challenges in biosimilars pricing and reimbursement policies in Europe and beyond
Abstract: Biosimilars policies are more controversial than those for generics. However, it is only a question of time before progress in biosimilars matches that of generics worldwide. Submitted: 21 April… Read More »
Physicians, Hippocrates and biosimilars: applying ancient principles in a modern society
Author(s): Adjunct Professor Pekka Kurki, MD, PhD
Page: 149-50
Abstract: Physicians are pondering the clinical use of biosimilars. A reliance on clinical trials is deeply rooted in the modern healthcare system, whereas comparability and totality of evidence remain unknown… Read More »
Adjusted indirect comparisons between generics – bioequivalence and interchangeability
Author(s): Professor László Tóthfalusi, MSc, PhD, Professor Laszlo Endrenyi, PhD, DSc
Page: 53-4
Abstract: Adjusted indirect comparisons are valuable to establish the bioequivalence and thereby the interchangeability between generic drug products. Limitations should be observed especially when several generics of a drug are… Read More »
Advances in analytical characterization of biosimilars
Abstract: The substantial improvement in the power of analytical methods to compare different versions of a given protein molecule should be taken into account when considering the value of clinical… Read More »
Biosimilars: patient and physician acceptability is the fifth hurdle to market competition
Author(s): Professor Alan Lyles, BSPharm, MPH, ScD
Page: 6-7
Abstract: Biosimilar products confront novel market authorization and post-marketing use hurdles. Existing evidence is insufficient to fully address physician and payer acceptability thresholds. Submitted: 4 March 2015; Revised: 5 March… Read More »
Availability and procurement of generics in hospitals among medium-sized European countries
Abstract: Dr Brian Godman reviews the paper by Vogler and co-authors on the procurement of generics or originators among European hospitals once multiple sources become available. Submitted: 28 November 2014;… Read More »
Regional regulatory processes for the approval of biosimilars; differences and similarities
Abstract: The situation in many countries regarding the procedure used to evaluate ‘biosimilars’ is not always clear. In this issue of GaBI Journal, Azevedo et al. review the regulatory situation… Read More »