News

Colombia issues draft decree for registration of biosimilars

Published on 2013/07/15

The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) announced on 21 January 2013 the release of a new draft guideline for biologicals, includi...

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When will the US biosimilars pathway be used

Published on 2013/07/12

FDA Commissioner Margaret Hamburg presented the latest statistics on the US biosimilar pathway during a speech at the Massachusetts Biotechnology Council’s (MassBio) Annual Meeting on 15 March 2013....

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Evergreening patents may make drugs too costly for patients in Thailand

Published on 2013/07/10

Many medicines will become too expensive for patients in Thailand in the near future if the government allows manufacturers to extend patents under the so-called ‘evergreen system’. Research into...

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Changes in risperidone use in Austria after introduction of generics

Published on 2013/07/08

Currently, many governments have introduced austerity reforms to control pharmaceutical expenditure. In Austria, efforts have been made to both increase the use and lower the prices of generics. The p...

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EU API law causing concern among API producers

Published on 2013/07/05

Under the Falsified Medicines Directive the European Union (EU) is introducing new rules for importing active pharmaceutical ingredients (APIs) for human-use medicines into Europe. From 2 January 2013...

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How are biosimilars special

Published on 2013/07/03

Despite biosimilars being around in the EU since 2006 physicians are still often reluctant to prescribe them. Members and experts of the Working Party on Similar Biologic Medicinal Products of the Eur...

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Fewer generics approved in the US during 2012

Published on 2013/07/01

FDA approved fewer generics for the US market during 2012 than in 2011, according to a new report from Thomson Reuters. A total of 506 generics were approved via abbreviated new drug applications ...

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Greece says no to automatic substitution of biologicals

Published on 2013/06/28

Greece’s Medicines Agency (National Organization for Medicines, Ethnikos Organismos Farmakon, EOF) released a document on 13 March 2013 recommending against automatic substitution/interchangeabili...

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Biosimilars bills move on in two US states

Published on 2013/06/26

The battle over biosimilar drugs is heating up in the US, with two states moving biosimilar bills along in the substitutability of biosimilars. In the Florida House, the Health Quality Subcommittee a...

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Use of venlafaxine in Austria after introduction of generics

Published on 2013/06/24

Trying to reduce expenditure on medicine is a major driving force for reforms by many governments. This includes Austria, where measures have been introduced to lower generics prices and enhance their...

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EMA releases guidelines on biosimilar interferon beta and r-FSH

Published on 2013/06/21

In March 2013, EMA released two guidelines on how pharmaceutical companies should test biosimilar medicines containing interferon beta and recombinant follicle stimulation hormone (r-FSH). Interferon...

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Japan approves second biosimilar G-CSF

Published on 2013/06/19

Japan has granted regulatory approval to a second biosimilar granulocyte colony-stimulating factor (G-CSF). The biosimilar G-CSF, filgrastim NK, is produced by Nippon Kayaku and development partner T...

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