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Biosimilars: when indications can be extrapolated

Published on 2015/07/28

Extrapolation* is already a well-established and accepted scientific and regulatory principle, according to members of the European Medicines Agency's (EMA) Biosimilar Medicinal Products Working P...

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Development of biosimilars for rheumatoid arthritis

Published on 2015/07/24

Biosimilars development is a hive of activity, with development of biosimilars for the treatment of rheumatoid arthritis being one of the busiest areas in the biosimilars field, see Table 1 [1]. ...

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Predicting the response of diabetes patients to biosimilar insulin

Published on 2015/07/22

For patients with type 1 diabetes, the quality of the insulin they take is a matter of life and death. The situation is similar for patients with type 2 diabetes. The question is what will these p...

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Biosimilars: similar but not identical

Published on 2015/07/20

One reason for distrust among physicians over using biosimilars in extrapolated* indications could be the fact that it is frequently cited that biosimilars are ‘similar but not identical’ comp...

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Study results show safety of switching to biosimilar infliximab

Published on 2015/07/16

US-based Epirus Biopharmaceuticals (Epirus) announced on 23 September 2014 positive week 58 follow-up data from its global phase III study for its biosimilar infliximab (BOW015). Results of the op...

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Patients satisfied with generics

Published on 2015/07/14

A report by health information resource, Iodine, has found that patients have a similar level of satisfaction with generics compared to brand-name drugs. The study into ‘Comparative Sat...

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Improved labelling sought for biosimilar acceptance

Published on 2015/07/10

The terms of approval for every biosimilar and its reference product must be made clearer, argue the European Biopharmaceutical Enterprises (EBE) [1]. The development of biosimilar regulatory path...

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Generics save US 1.5 trillion over last 10 years

Published on 2015/07/08

Generics have saved consumers and the US healthcare system US$239 billion in 2013 and have saved the US nearly US$1.5 trillion between 2004 and 2013, according to a report by the Generic Pharmaceu...

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Changes to pharmaceutical policy during an economic recession

Published on 2015/07/06

The use of antipsychotic medicines across Finland and Portugal following the recent economic recession have been analysed in order to gauge the impact of contrasting pharmaceutical policy interven...

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Biosimilar bevacizumab similar to Avastin in preclinical assessments

Published on 2015/07/02

Amgen’s biosimilar bevacizumab candidate (ABP 215) to Avastin [1]. Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by block...

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Extrapolation for biosimilars

Published on 2015/06/30

Regarding extrapolation* of indications for biosimilars, the European Medicines Agency (EMA) has stated that ‘if clinical similarity can be shown in a key indication, extrapolation of efficacy a...

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Mobilization of stem cells by biosimilar Nivestim and Neupogen

Published on 2015/06/29

Comparison of biosimilar granulocyte colony-stimulating factor (G-CSF), Nivestim and originator G-CSF, Neupogen (filgrastim), showed no statistical differences when used for the mobilization of pe...

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