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Biosimilars approved in South Korea Biosimilars/General | Posted 14/03/2014

Last update: 2 December 2016In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly t...

EMA and FDA extend quality collaboration Policies & Legislation | Posted 14/03/2014

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 prog...

Protein aggregation and the generation of immune responses Biosimilars/Research | Posted 14/03/2014

During a presentation given by Ms Melody Sauerborn (TNO Triskelion, The Netherlands) at an international conference on biowaivers and biosimilars, held in the US in September 2012, the immunologica...

Use of generic cardiovascular drugs in China Generics/Research | Posted 07/03/2014

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 t...

Biosimilar epoetin-κ equivalent to epoetin-β Biosimilars/Research | Posted 07/03/2014

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...

European trade organizations worried about pharmacovigilance fees Policies & Legislation | Posted 07/03/2014

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.

Biosimilars approved in Japan Biosimilars/General | Posted 07/03/2014

Last update: 14 October 2016In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry for Health Labour and Welfare (MHLW).

Actavis to acquire specialty drugmaker Forest Labs Pharma News | Posted 07/03/2014

US-based generic drugmaker Actavis is set to grow even bigger, with the acquisition of US-based Forest Laboratories (Forest Labs), according to an announcement by the companies on 18 February 2014.