Physicians, Hippocrates and biosimilars: applying ancient principles in a modern society

Published in: Volume 5 / Year 2016 / Issue 4
Page: 149-150

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

Published in: Volume 5 / Year 2016 / Issue 2
Author(s): ,
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

Published in: Volume 4 / Year 2015 / Issue 3
Page: 107, 109

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

Published in: Volume 4 / Year 2015 / Issue 1
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

Published in: Volume 3 / Year 2014 / Issue 4
Page: 162-3

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

Published in: Volume 3 / Year 2014 / Issue 3
Page: 106

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

Published in: Volume 3 / Year 2014 / Issue 2
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

Published in: Volume 3 / Year 2014 / Issue 1
Page: 6-7

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?

Published in: Volume 2 / Year 2013 / Issue 4
Author(s): ,
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 »

Suggested evaluation of biological drugs role for WHO – Editor’s response

Published in: Volume 2 / Year 2013 / Issue 4
Page: 162

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… Read More »

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