Letters to the Editor
No need for systematic switch studies to demonstrate interchangeability of biosimilars
Author(s): Adjunct Professor Pekka Kurki, MD, PhD
Page: 5-6
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.… Read More »
Comment on the non-biological complex drugs paper
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… Read More »
Clear naming, traceability of biological medicines will protect patients
Author(s): Alejandro Mercedes, MD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Brian Bressler, MD, Madelaine A Feldman, MD, FACR
Page: 153-4
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:… Read More »
Pricing strategies for pharmaceuticals in developing countries: what options do we have?
Author(s): Nada Moustafa Abdel Rida, MSc Candidate, Professor Mohamed Izham Mohamed Ibrahim, PhD
Page: 4-6
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:… Read More »
Is the EU ready for non-biological complex drug products?
Author(s): Beat Flühmann, PhD, Jon SB de Vlieger, PhD, Professor Gerrit Borchard, PharmD, PhD, Professor Stefan Mühlebach, PhD, Sesha Neervannan, PhD, Vinod P Shah, PhD
Page: 101-2
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… Read More »
First biosimilar of infliximab approved in Brazil: response from the Brazilian IBD society
Author(s): Professor Fabio V Teixeira, MSc, MD, PhD
Page: 4-5
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… Read More »
Access to safe and effective biopharmaceuticals
Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath
Page: 108-9
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… Read More »
Generic medicines policy in Qatar
Author(s): Professor Mohamed Izham Mohamed Ibrahim, PhD
Page: 8
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… Read More »
Access to alternative biopharmaceuticals in low- and middle-income countries
Author(s): Professor Abdol Majid Cheraghali, PharmaD, PhD
Page: 164-5
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.… Read More »
Common or distinct INN for biosimilars? Only characteristics of the active substance prior to formulation should be considered
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… Read More »