Author byline as per print journal: Hillel P Cohen, PhD; Caridad Pontes, MD, PhD; Fernando de Mora, MBA, PhD Abstract: The critique of Reilly and McKibben of the meta-analysis conducted by Herndon et al. is factually flawed on several important points. As a result, the conclusions of Reilly and McKibben are not scientifically substantiated. Submitted: […]
Abstract: Reilly and McKibbin oppose the update of FDA interchangeability guidance that does not require clinical switch studies. However, their arguments lack a scientific basis. Submitted: 3 December 2024; Revised: 17 December 2024; Accepted: 18 December 2024; Published online first: 18 December 2024 Comment on the article by Reilly MS and McKibbin RD: Misinformation about interchangeable biosimilars […]
Abstract: Systematic clinical switch studies to demonstrate interchangeability of biosimilars are required in some jurisdictions while theoretical considerations and current clinical data question the feasibility and relevance of such studies. Submitted: 27 November 2021; Revised: 15 December 2021; Accepted: 15 December 2021; Published online first: 28 December 2021 Biosimilars have been used for 15 years […]
Abstract: Comment on the Special Report by Professor Gerrit Borchard: Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias, published in GaBI Journal, 2016;5(1):36-41. Submitted: 3 November 2017; Revised: 13 November 2017; Accepted: 15 November 2017; Published online first: 28 November 2017 We thank you for publishing the manuscript entitled ‘Complexity in the making: non-biological […]
Author byline as per print journal: Adjunct Professor Valderilio Feijó Azevedo, MD, PhD, MBA; Associate Professor Brian Bressler, MD, MS, FRCPC; Madelaine A Feldman, MD, FACR; Professor Alejandro Mercedes, MD Abstract: As more biological medicines and biosimilars become increasingly available worldwide, clear product identification is critical for accurate pharmacovigilance. Submitted: 25 September 2017; Revised: 25 September […]
Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Gerrit Borchard, PharmD, PhD; Vinod P Shah, PhD; Beat Flühmann, PhD; Sesha Neervannan, PhD; Professor Stefan Mühlebach, PhD Abstract: Comment on the Regulatory paper by Dr Falk Ehmann and Dr Ruben Pita: The EU is ready for non-biological complex medicinal products, published in […]
Abstract: Effective pharmaceutical pricing policies in developing countries are important to ensure accessibility and affordability of essential medicines for the people. Submitted: 24 October 2016; Revised: 27 February 2017; Accepted: 28 February 2017; Published online first: 13 March 2017 In developing countries, essential medicines are not always available to those who need them because of […]
Abstract: CT-P13 was the first infliximab biosimilar approved in Brazil. Approval was granted for all indications of the innovator. Despite similar efficacy and safety, vigilance remains essential. Submitted: 4 January 2016; Revised: 27 January 2016; Accepted: 1 February 2016; Published online first: 12 February 2016 On 27 April 2015, the Brazilian Health Surveillance Agency (Agência […]
Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract: Comment on the Letter to the Editor by Professor Abdol Majid Cheraghali: Access to alternative biopharmaceuticals in low- and middle-income countries, published in GaBI Journal, 2014;4(3):164-5. Submitted: 7 June 2015; Revised: 8 June 2015; Accepted: 8 June 2015; Published online first: 22 […]
Abstract: Qatar’s pharmaceutical market is likely to remain highly dependent on imports. The use of generic medicines remains a great challenge to the country. Submitted: 18 December 2014; Revised: 28 January 2015; Accepted: 1 February 2015; Published online first: 13 February 2015 Qatar is the world’s richest country per capita. The country established its National […]
Abstract: Alternative biopharmaceuticals could substantially improve affordability of biotherapeutics in developing countries. However, it seems that these countries need a modified regulatory pathway to guarantee timely access to these medicines. Submitted: 27 August 2014; Revised: 14 September 2014; Accepted: 15 September 2014; Published online first: 29 September 2013 In recent years, biotherapeutics have gained a […]
Submitted: 24 January 2014; Revised: 29 January 2014; Accepted: 30 January 2014; Published online first: 12 February 2014 To the Editor: I read with interest the letter of Dr Edward T Maggio which was published in Volume 2/Year 2013/Issue 4 of the Generics and Biosimilars Initiative Journal [1] on the naming issue for biosimilars and […]
