Letters to the Editor

No need for systematic switch studies to demonstrate interchangeability of biosimilars

Published in: Volume 11 / Year 2022 / Issue 1
Author(s):
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

Published in: Volume 6 / Year 2017 / Issue 4
Author(s):
Page: 154, 6

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

Published in: Volume 6 / Year 2017 / Issue 4
Author(s): , , ,
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?

Published in: Volume 6 / Year 2017 / Issue 1
Author(s): ,
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?

Published in: Volume 5 / Year 2016 / Issue 3
Author(s): , , , , ,
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

Published in: Volume 5 / Year 2016 / Issue 1
Author(s):
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

Published in: Volume 4 / Year 2015 / Issue 3
Author(s): ,
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

Published in: Volume 4 / Year 2015 / Issue 1
Author(s):
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

Published in: Volume 3 / Year 2014 / Issue 4
Author(s):
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

Published in: Volume 3 / Year 2014 / Issue 1
Author(s):
Page: 8

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 »

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