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International harmonization for biosimilars

Published on 2013/10/14

What is the possibility of international harmonization for biosimilars? EMA Head of Biologicals Dr Peter Richardson and Amgen Director of Value, Access and Policy Mr Thomas Moore speak to BioCentury a...

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Enhancing prescribing efficiency in the Republic of Srpska

Published on 2013/10/11

It has been claimed that countries with smaller populations have difficulties obtaining considerable price reductions for generics. However, evidence from the Republic of Srpska, which is one of the t...

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Biosimilar monoclonal antibodies and pharmacovigilance in Europe

Published on 2013/10/09

EMA Head of Biologicals Dr Peter Richardson and Amgen Director of Value, Access and Policy Mr Thomas Moore speak to BioCentury about biosimilar monoclonal antibodies and pharmacovigilance for biosimil...

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Robust data for biosimilar trastuzumab programmes presented

Published on 2013/10/07

Celltrion and Pfizer have presented robust data from their respective biosimilar trastuzumab programmes at the ASCO (American Society of Clinical Oncology) 2013 Annual Meeting held on 31 May to 4 June...

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Possibility of substitution of biosimilars in Europe

Published on 2013/10/04

To date, 14 biosimilars within the product classes of human growth hormone (1), granulocyte colony-stimulating factor (8) and erythropoietin (5) have been approved in Europe. EMA Head of Biologicals D...

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Use of G-CSF biosimilars for reduction of fever

Published on 2013/10/02

The American Society of Hematology, the British Society of Haematology, the European Society of Hematology and the European Group of Bone Marrow Transplantation all recommend the use of granulocyte co...

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Biologicals sales have almost doubled since 2006

Published on 2013/09/30

Sales of biologicals have almost doubled from US$63.8 billion in 2006 to US$124.6 billion in 2012. During this time period, the best selling therapeutic classes have also changed. Back in 2006, eryth...

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Use of G-CSF biosimilars for stem cell mobilization in autologous transplantation

Published on 2013/09/27

The first biosimilar granulocyte colony-stimulating factor (G-CSF) was licensed by EMA in 2008, and there are currently six biosimilar G-CSF products licensed for use in the EU. All of these biosimila...

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Positive post-marketing data for biosimilar epoetin

Published on 2013/09/25

Injectable generics specialist, Hospira, presented results from a post-marketing study of the company’s European biosimilar epoetin (Retacrit) on 3 June 2013 at the 48th Annual Meeting of the Americ...

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Biopharmaceutical products in Iran

Published on 2013/09/23

Iran will become a leader in biotechnology products (especially copied biopharmaceuticals) in Asia over the next three years, according to a review by Mahboudi et al. Over the last two decades the Ir...

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Equivalence of generic immunosuppressants

Published on 2013/09/20

There are no compelling pharmacological arguments against the sensible use of the generic immunosuppressants ciclosporin, tacrolimus and mycophenolate mofetil in clinical practice, argue pharmacologis...

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Use of G-CSF biosimilars for stem cell mobilization in healthy donors

Published on 2013/09/18

Granulocyte colony-stimulating factor (G-CSF) can be used to mobilize peripheral blood stem cells (PBSCs) in healthy donors. Over the last 10 years, the procedure has become the preferred option for d...

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