Search results for Editorial

Biosimilars in oncology: beyond regulation—building confidence through evidence and dialogue

Abstract: This editorial discusses systemic barriers limiting oncology biosimilar adoption in Chile and Latin America, emphasizing trust, education, and coordinated policy actions to strengthen value, equity, and confidence in biosimilars. The manuscript by Paredes-Fernández and Lenz-Alcayaga [1] addresses a key but often neglected question in Latin America: why have biosimilars, despite their proven safety, efficacy, […]

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Rising costs of biologicals: effective cost-containment does not please all stakeholders

Abstract: Rieger and Holland provided a report of a stakeholder meeting dealing with the biosimilar uptake in Australia. The proposed policy measures reported may not have a dramatic effect on the biosimilar uptake. From the scientific and medical point of view, the biotech industry has developed wonderful medicines for treating chronic and life-threatening diseases. Unfortunately, […]

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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 a number of changes to the regulatory processes currently in place for biosimilars. This response letter considers the implications and consequences of these. Submitted: 8 December […]

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Is the local tolerance of injectable biosimilars too underestimated?

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; Revised: 2 October 2020; Accepted: 6 October 2020; Published online first: 12 October 2020 The previous issue of GaBI Journal published a manuscript entitled ‘Systematic […]

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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 2017; Revised: 28 April 2017; Accepted: 2 May 2017; Published online first: 15 May 2017 Healthcare systems worldwide are under increasing pressure due to the […]

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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 concepts. This editorial explores these ideas, with reference to a case study of Italian gastroenterologists. Submitted: 24 October 2016; Revised: 1 November 2016; Accepted: 1 […]

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Adjusted indirect comparisons between generics – bioequivalence and interchangeability

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 marketed. Submitted: 14 June 2016; Revised: 23 June 2016; Accepted: 24 June 2016; Published online first: 4 July 2016 A recent review discussed adjusted indirect […]

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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 studies for designation of biosimilarity. Arguably, demonstration of comparative pharmacokinetic, allied to post-registration monitoring, will provide more discriminatory clinical evidence than large pre-approval therapeutic equivalence […]

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Biosimilars: patient and physician acceptability is the fifth hurdle to market competition

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 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 In this issue of GaBI Journal, Sandorff et al. [1] investigate payer and physician […]

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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; Revised: 3 December 2014; Accepted: 3 December 2014; Published online first: 16 December 2014 Vogler and co-authors have provided valuable insight into the procurement of […]

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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 for biosimilars in Latin America. It is intended to publish reviews covering the regulatory situation with biosimilars in other countries/geographical areas in future issues of […]

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Complex molecules – current developments

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 […]

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