Editorial
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
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 Laszlo Endrenyi, PhD, DSc, Professor László Tóthfalusi, MSc, PhD
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, ScD, MPH, RPh
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 conditions 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 »
Complex molecules – current developments
Author(s): Professor Gerrit Borchard, PharmD, PhD
Page: 54-5
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… Read More »
Drug shortages hit US oncologists hard
Abstract: The number of drug shortages in the US has tripled between 2006 and 2012, with drug shortages now affecting most US oncologists and impacting on patient care. There is… Read More »
Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise?
Author(s): Armando A Genazzani, DPhil, MD, Nicola Magrini, MD
Page: 163-4
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… Read More »