Commentary

Biosimilar monoclonal antibodies approved for use in the EU

Published in: Volume 3 / Year 2014 / Issue 1
Author(s): ,
Page: 9-10

Abstract: Two biosimilar TNF-alfa monoclonal antibody (mAb) products were approved for clinical use in the European Union on 10 September 2013, following a positive opinion by the Committee for Medicinal… Read More »

Maximizing quality in the manufacture of biologicals

Published in: Volume 2 / Year 2013 / Issue 4
Author(s): ,
Page: 170-2

Abstract: Biological product quality is susceptible to unexpected manufacturing issues, and the resulting variation may impact the safety or efficacy of these medicines and increase risks to patients. These risks… Read More »

Ongoing initiatives in the Republic of Srpska to enhance prescribing efficiency; influence and future directions

Published in: Volume 2 / Year 2013 / Issue 3
Author(s):
Page: 112-3

Abstract: Dr Brian Godman reviews the paper by Markovic-Pekovic et al. regarding recent reforms in the Republic of Srpska. These include prescribing restrictions where concerns with the value of products… Read More »

Biosimilar monoclonal antibodies—challenges and opportunities in Europe

Published in: Volume 2 / Year 2013 / Issue 3
Author(s):
Page: 110-1

Abstract: New regulations for the development of biosimilars have been introduced in Europe and a new class of biosimilars – monoclonal antibodies – is expected on the market soon, which… Read More »

Commentary on the recommendations of the European Society for Organ Transplantation Advisory Committee on generic substitution of immunosuppressive drugs

Published in: Volume 2 / Year 2013 / Issue 3
Author(s):
Page: 108-9

Abstract: In 2010, the Council of the European Society for Organ Transplantation formed an Advisory Committee to formulate recommendations on the use of generic drugs in solid organ transplant recipients.… Read More »

The case for biosimilars–a payer’s perspective

Published in: Volume 2 / Year 2013 / Issue 1
Author(s):
Page: 12

Abstract:  Biosimilars have the potential for making savings in healthcare costs, and with resource allocation, if competition is permitted at the level of treatment induction. Submitted: 24 August 2012; Revised: 17 January 2013; Accepted: 4… Read More »

Pharmacovigilance of biosimilars: challenges and possible solutions

Published in: Volume 1 / Year 2012 / Issue 3-4
Author(s): ,
Page: 118-9

Author byline as per print journal: Thijs J Giezen, PharmD, PhD; Sabine MJM Straus, MD, PhD Abstract:  Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small… Read More »

Statin generics: no differences in efficacy after switching

Published in: Volume 1 / Year 2012 / Issue 3-4
Author(s):
Page: 116-7

Abstract:  A study presented at the 2010 Congress of the European Society of Cardiology, had created a considerable stir. Its abstract allegedly showed that the originator drug Lipitor was more… Read More »

Innovator companies should focus on innovations

Published in: Volume 1 / Year 2012 / Issue 1
Author(s):
Page: 6

Abstract: Despite biopharmaceuticals having an enormous potential value for our health, they have also become a serious threat to our healthcare systems. Submitted: 22 June 2011; Revised manuscript received: 6… Read More »

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