Original Research

Alternative statistical strategies for biosimilar drug development

Published in: Volume 3 / Year 2014 / Issue 1
Author(s): , , ,
Page: 13-20

Introduction: Many regulatory authorities have published requirements for the approval of biosimilar medicinal products. However, there is no guidance on which quantitative standards should be used to define how similar… Read More »

Establishment of reference standards in biosimilar studies

Published in: Volume 2 / Year 2013 / Issue 4
Author(s): , ,
Page: 173-7

Abstract: When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative… Read More »

Assessing biosimilarity using the method of generalized pivotal quantities

Published in: Volume 2 / Year 2013 / Issue 3
Author(s): ,
Page: 130-5

Author byline as per print journal: Shih-Ting Chiu, PhD, Chen Chen, MSc, Professor Shein-Chung Chow, PhD, Eric Chi, PhD Introduction: For generic approval of small-molecule (chemical) drug products, US Food… Read More »

Regional tenders on biosimilars in Italy: potentially competitive?

Published in: Volume 2 / Year 2013 / Issue 3
Author(s): , , , ,
Page: 123-9

Author byline as per print journal: Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Roberta Lo Muto, MSc, Silvy Duranti, MBA, Professor Livio Garattini Introduction: Health care in Italy is… Read More »

Efficient production of recombinant parathyroid hormone (rPTH) fragment 1-34 in the methylotrophic yeast Hansenula polymorpha

Published in: Volume 2 / Year 2013 / Issue 3
Author(s): ,
Page: 114-22

Author byline as per print journal: Frank Mueller, MSc, Manal Moussa, MSc, Maria El Ghazaly, MSc, Jan Rohde, PhD, Nicole Bartsch, MSc, Antje Parthier, PhD, Frank Kensy, Dr Ing Background:… Read More »

How do regional sickness funds encourage more rational use of medicines, including the increase of generic uptake? A case study from Austria

Published in: Volume 2 / Year 2013 / Issue 2
Author(s): ,
Page: 65-75

Objective: To analyse similarities and differences between activities carried out by Austrian sickness funds to encourage more rational use of medicines, including increasing generics uptake. Methods: Semi-structured interviews with pharmacoeconomic… Read More »

The generic pharmaceutical industry: moving beyond incremental innovation towards re-innovation

Published in: Volume 2 / Year 2013 / Issue 1
Author(s): , ,
Page: 13-9

Background: Due to the declining innovativeness of the classic R & D model in the original pharmaceutical industry, the generic pharmaceutical industry is aiming to become an innovation generator itself.… Read More »

Saving money in the European healthcare systems with biosimilars

Published in: Volume 1 / Year 2012 / Issue 3-4
Author(s): , , ,
Page: 120-6

Introduction: The use of biotechnological manufactured drugs, or biologicals, has increased massively over the past few years. Used especially in the treatment of cancer and other severe diseases, biologicals incur high… Read More »

The assessment of biosimilarity with SABE and IBE criteria under a switching/alternating design

Author(s): , ,

Abstract: The development of biosimilars has become one of the most rapidly evolving areas in recent years as key biological drug products are losing their patent protection. Unlike small molecule… Read More »

Biosimilars for Healthcare Professionals

Author(s):

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