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Biosimilars knowledge gap needs addressing

Published on 2014/12/09

The European Generic medicines Association (EGA) has called upon national authorities and medical societies to actively engage in reducing the knowledge gap about biosimilars. EGA addressed a...

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Regulatory principles for biosimilar monoclonal antibodies

Published on 2014/12/05

It is sometimes argued that there is less clinical evidence for biosimilars. However, Tsiftsoglou and co-authors pointed out that European Medicines Agency (EMA) guidelines for biosimilars are not p...

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Australian price cuts make PBS affordable

Published on 2014/12/03

The price cuts for 121 medicines supplied through Australiaâ€™s Pharmaceutical Benefits Scheme (PBS) have made the PBS sustainable, according to Medicines Australia, a group that represents ori...

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Development of Iranian guidelines for â€˜biogenericsâ€™

Published on 2014/12/01

The national regulatory authority for approval of medicines in Iran, the Iranian Food and Drug Organization (FDO), has issued its new guidelines for registration of biologicals (recombinant medicine...

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FDA discredits study claiming foreign generics tainted

Published on 2014/11/27

Research suggesting that foreign generics are inferior to US generics has been discredited by the FDAâ€™s Center for Drug Evaluation and Research Director Dr Janet Woodcock. The study by...

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WHO investigates use of a biological qualifier for biosimilars

Published on 2014/11/25

The World Health Organization is still discussing several different options on how to name biosimilars, according to the recently published executive summary of its 57th Consultation on Internationa...

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The generics market in China

Published on 2014/11/21

Market access barriers remain the main challenge for generics in China, according to a presentation by Xianghong Shao given at the International Generic Pharmaceutical Alliance (IGPA)â€™s 16th ...

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US FTC hopes to collect US$1 billion from pay-for-delay settlement

Published on 2014/11/19

The US Federal Trade Commission (FTC) is looking to collect more than US$1 billion from a settlement with pharmaceutical companies it has sued for their part in what the FTC terms â€˜pay-for-del...

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Cost savings and use of generics in Europe

Published on 2014/11/17

Generics provide significant savings for the healthcare systems, as well as increased access to medicines, in the European Union (EU). This is according to a presentation by Mr Victor Lino MendonÃ�...

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Bill proposes extension of patents for new uses of biologicals

Published on 2014/11/13

A new bill, introduced in the US House of Representatives on 24 March 2014, proposes allowing patent owners to extend terms for certain biological patents if they are approved for new indications. ...

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Cost savings to be made by switching to Zarzio

Published on 2014/11/11

Since the first filgrastim biosimilar was approved in 2008, there is now five years of data on which to assess the efficacy, safety and cost-effectiveness of biosimilar granulocyte colony-stimulatin...

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Anticompetitive practices come under scrutiny in Australia

Published on 2014/11/07

The Australian Competition and Consumer Commission (ACCC) has started proceedings in the Federal Court against Pfizer Australia (Pfizer) alleging that offers made by Pfizer to pharmacies before the ...

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