New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications

Published in: Volume 5 / Year 2016 / Issue 2
Author(s): , , , ,
Page: 66-9

Author byline as per print journal: Valderílio Feijó Azevedo1,2, Alejandra Babini3,4, Fabio Vieira Teixeira5,6, Igor Age Kos1,2, Pablo Matar7 Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual… Read More »

Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section

Published in: Volume 4 / Year 2015 / Issue 4
Author(s): , , , , , , , ,
Page: 167-70

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Stefan Mühlebach, PhD; Vinod P Shah, PhD; Scott E McNeil, PhD; Professor Gerrit Borchard, PharmD, PhD; Vera Weinstein, PhD; Beat Flühmann,… Read More »

Substantial savings with generics in Austria – and still room for more

Published in: Volume 4 / Year 2015 / Issue 3
Page: 141-2

Abstract: Austria has seen considerable savings with generics, due to its unique pricing system. Generic medicine penetration is, however, not as advanced as in other European countries. Additional savings could… Read More »

The implementation of generics in France

Published in: Volume 4 / Year 2015 / Issue 3
Author(s): ,
Page: 136-40

Abstract: The first recognized and trusted generic drugs were launched in France in 1995, at the same time that the Prime Minister Alain Juppé introduced his new plan on Retirement… Read More »

Norway, biosimilars in different funding systems. What works?

Published in: Volume 4 / Year 2015 / Issue 2
Page: 90-2

Abstract: Biosimilars can substitute treatment with expensive biological drugs and release money to treat more patients. Experience from Norway shows how this can be done with and without success. Submitted:… Read More »

Biosimilars for prescribers

Published in: Volume 4 / Year 2015 / Issue 1
Page: 33-5

Abstract: Biosimilars are copies of original biological medicines. Biosimilarity is a new concept in drug development. Physicians prescribing biologicals need more neutral information on the quality, safety and efficacy of… Read More »

Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses

Published in: Volume 3 / Year 2014 / Issue 3
Author(s): , ,
Page: 150-4

Abstract: The principles Health Canada use when extrapolating the indications and uses of a biosimilar product subsequent to a single clinical trial or limited number and scope of clinical trials… Read More »

Role of hospital clinical pharmacist in transplantation, and generic immunosuppressive therapies

Published in: Volume 3 / Year 2014 / Issue 2
Page: 95-8

Abstract: The pharmacist is an important patient advocate in the transplant multidisciplinary team and can support patients in their medication taking to improve medication adherence. Medicine optimization and patient information… Read More »

Assuring patient-centred care: engaging patients with rheumatoid arthritis in disease monitoring and pharmacovigilance

Published in: Volume 3 / Year 2014 / Issue 1
Page: 26-8

Abstract: With the advent of complex therapies in the form of biologicals, emerging biosimilars and non-biological complex drugs, monitoring for treatment related benefit and the potential for adverse effects is… Read More »

Licensing and prescribing biosimilars in Australia

Published in: Volume 2 / Year 2013 / Issue 3
Page: 152-4

Abstract: Some years ago, Australian regulatory authorities decided to follow the path laid down by the European Medicines Agency in adopting a process for approval of biosimilars. This has been… Read More »

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