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EMA issues concept paper for revision of immunogenicity guideline

Published on 2014/11/05

On 25 March 2013 the European Medicines Agency (EMA) announced the publication of a concept paper to discuss the revision of the guideline on immunogenicity assessment of biotechnology-derived thera...

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Indiana biosimilars substitution bill becomes law

Published on 2014/11/03

Indiana Governor Mike Pence signed into law on 25 March 2014 legislation that will allow pharmacists to substitute biosimilars that the US Federal Drug Administration (FDA) has approved as interchan...

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The non-financial benefits of generics substitution

Published on 2014/10/30

Switching between different generic brands of metformin is a good cost-effective approach that does not adversely affect the quality of care for patients with type 2 diabetes, according to the resul...

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European doctors have insufficient knowledge of biosimilars

Published on 2014/10/28

The Alliance for Safe Biologic Medicines (ASBM), which represents patients and physicians, as well as originator biological and biosimilar medicines companies in the US, published results of a surve...

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Diabetes and high blood pressure generics in Europe

Published on 2014/10/24

Generics contribute value to the European Union (EU), according to a presentation by Mr Victor Lino MendonÃ§a given at the International Generic Pharmaceutical Alliance (IGPA)â€™s 16th Annual...

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Proposal in Brazil to exempt medicines from tax

Published on 2014/10/22

The Brazilian Government announced on 9 February 2014 that it is setting up a committee to evaluate whether to exempt medicines from tax in the country. The joint committee will be set up in order ...

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GPhA proposes using manufacturer names to distinguish biosimilars

Published on 2014/10/20

The Generic Pharmaceutical Association (GPhA) has proposed a compromise naming scheme for biosimilars that it hopes will end the dispute over how to assign international non-proprietary names (INNs)...

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Are biosimilars worth it?

Published on 2014/10/16

Will off-patent biological medicines offer the same cost savings as those seen with off-patent non-biological (chemically derived) medicines? A group of health economists based in Brussels, Belgium,...

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EMA and FDA extend quality collaboration

Published on 2014/10/14

The European Medicines Agency (EMA) announced on 6 March 2014 that as of 1 April 2014 EMA and the US Food and Drug Administration (FDA) have agreed on a two-year extension of their joint pilot progr...

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Brand-name drugs also cut healthcare costs

Published on 2014/10/10

Generics are often given all the praise when it comes to cutting costs for patients and payers, but, according to a piece in Forbes, brand-name drugs also cut healthcare costs. Generics, it i...

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How safe is Zarzio after five yearsâ€™ clinical experience?

Published on 2014/10/08

The first filgrastim biosimilar was approved in Europe in 2008, prompting Dr Pere GascÃ³n and co-authors to review the evidence relating to the efficacy and safety of biosimilar Zarzio (filgrastim...

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Generics contribution to availability of essential medicines

Published on 2014/10/06

The creation of Essential Medicines Lists (EMLs) within country healthcare systems is promoted by the World Health Organization (WHO) in order to improve the availability and use of medicines consid...

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