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How safe is Zarzio after five years’ clinical experience? Biosimilars/Research | Posted 14/03/2014

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

Brand-name drugs also cut healthcare costs Generics/General | Posted 14/03/2014

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.

Amgen starts another phase III trial for biosimilar adalimumab Biosimilars/News | Posted 14/03/2014

US biotechnology giant Amgen has started recruiting for a phase III clinical trial of its biosimilar adalimumab in patients suffering from plaque psoriasis, according to the US clinical trials webs...

FDA approves generic osteoporosis drug Generics/News | Posted 14/03/2014

FDA announced on 4 March 2014 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Eli Lilly’s osteoporosis drug Evista (raloxifene).

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

Last update: 22 January 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...