GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative

Volume 5 / Year 2016 / Issue 3

Perspective

Biosimilars in Italy: a gastroenterologist’s view

Author(s): Antonio Luca Annese, MD, Tommaso Gabbani, MD, Vito Annese, MD

Page: 131-3

Author byline as per print journal: Vito Annese, MD; Tommaso Gabbani, MD; Antonio Luca Annese, MD Abstract: The introduction of biological therapy has revolutionized the paradigm of treatment in the last two decades. This is expected to lead to corresponding amelioration of the course of several immune-mediated diseases, including inflammatory bowel diseases (IBD). However, this […]

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Are the perspectives regarding the use of biosimilars in the setting of haematology and blood and marrow transplant changing?

Author(s): Cherie C Severson, RN, MN, CON(C), BMTCN

Page: 128-30

Introduction: Canada is among the leading spenders in pharmaceuticals. Based on projected figures, the cost of pharmaceuticals is expected to rise by another 6–12% by 2023. Approximately CAN$4.6 billion of healthcare funding is spent on biological drugs (including growth factors and monoclonal antibodies) which are commonly used in the setting of haematology and blood and […]

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Regional management of biosimilars in Germany

Author(s): Mathias Flume, MBA, PhD

Page: 125-7

Abstract: Biosimilars of tumour necrosis factor-alpha (TNF-α) inhibitors, such as infliximab or etanercept, have recently entered the market. The management of these new products by the healthcare systems differ between European countries, and there may be regional differences within countries. This paper describes prescription structures and approaches to manage the uptake of biosimilars in Germany. […]

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Pharmacovigilance on biologicals and biosimilars: a Danish perspective

Author(s): Benedicte Lunddahl, DVM

Page: 123-4

Abstract: The development of biological medicinal products is in rapid growth and as patents for reference products expire, new biosimilar products become available. This has a marked impact on several stakeholders; from patients and physicians to decision-makers, and on activities; from treatment of patients to the conduct of pharmacovigilance. The Danish Medicines Agency (Laegemiddelstyrelsen, DKMA) […]

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Last update: 28/10/2016

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