News

Biosimilars approved in Japan

Published on 2014/10/02

In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry for Health Labour and Welfare (MHLW). The Pharmaceuticals and Medical Devices Agency (PMDA)...

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European trade organizations worried about pharmacovigilance fees

Published on 2014/09/30

Some of Europe’s major trade associations have expressed their concerns over fees being proposed by the European Medicines Agency (EMA) as part of new European Union (EU) pharmacovigilance rules. ...

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Biosimilar epoetin-κ equivalent to epoetin-β

Published on 2014/09/26

In 1989, the first recombinant erythropoietin (rEPO) preparation, epoetin-α, was approved by the US Food and Drug Administration for the treatment of anaemia associated with kidney disease. Since t...

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Use of generic cardiovascular drugs in China

Published on 2014/09/24

China has not yet recognized the importance of increasing generics use as a method to reduce drug prices. An analysis of drug prices in hospitals in the Chongqing province in China has shown that th...

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Biosimilars approved in Australia

Published on 2014/09/22

In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989. The regulatory body for therapeutic goods in Australia is the Therapeutic Goods A...

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FDA and Health Canada streamline drug submissions

Published on 2014/09/18

The US Food and Drug Administration (FDA) and Health Canada have joined forces to launch the Common Electronic Submissions Gateway. Drug companies will be able to use the gateway to send drug author...

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FDA starts widespread testing of generics

Published on 2014/09/16

The US Food and Drug Administration (FDA) has allocated US$20 million for testing generics and has already been assessing generics since September 2013, despite no announcement having been made. Th...

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Compliance and persistence same for generic and brand-name alendronate

Published on 2014/09/12

A retrospective analysis of data in Italy has shown that patients taking generic and brand-name alendronate showed the same rates of persistence and compliance [1]. Alendronate is used to tre...

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Inflammatory arthritis: auditioning for the role of biosimilar

Published on 2014/09/10

Targeted biological therapies have proven themselves highly effective in the treatment of inflammatory joint diseases, but their benefits are restricted by cost. Biosimilars of these therapies would...

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EU majority says same INNs for biosimilars

Published on 2014/09/08

According to recently published summary minutes from an October 2013 meeting of the European Commission’s Pharmaceutical Committee, the majority of EU Member States agree that biosimilars should h...

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New Zealand guidelines for biosimilars

Published on 2014/09/04

The regulatory body for approval of medicines in New Zealand is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The agency is responsible for the regulation of medicines an...

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FDA’s labelling proposal will increase cost of generics

Published on 2014/08/14

In November 2013 the US Food and Drug Administration (FDA) proposed a new rule which would allow generics makers to change their labelling in the same way as brand-name manufacturers [1]. However, a...

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