News

South Korean guidelines for biosimilars

Published on 2012/04/11

The regulatory body for approval of medicines in South Korea is the Korean Food and Drug Administration (KFDA). The agency, through its Biopharmaceuticals and Herbal Medicines Bureau, is responsible f...

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Savings to be made from generics use in Australia

Published on 2012/04/10

Increasing the use of generic drugs in Australia could generate ‘hundreds of millions of dollars in savings’ for Australia’s Pharmaceutical Benefits Scheme (PBS) in 2012, ‘eliminating the need...

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Generics saved Germany more than 25% in 2011

Published on 2012/03/23

The increased use of generics in Germany has brought about record savings of more than 25% in 2011 compared with 2010. The increased savings have been attributed to the success of measures put in plac...

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FDA discusses biosimilars guidance

Published on 2012/03/22

FDA issued its long-awaited guidance for biosimilar applications on 10 February 2012 in the form of three draft guidance documents. In a webinar on 15 February 2012 FDA discussed some of the issues su...

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Impact of measures to encourage generics prescribing in Scotland

Published on 2012/03/21

Since 2000, measures have been introduced in Scotland in order to encourage use of generic rather than brand-name proton pump inhibitors (PPIs) and statins. The impact of these measures on the prescri...

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Biosimilars interchangeability, increased costs and burden for FDA

Published on 2012/03/20

Biosimilars manufacturers in the US are faced with many hurdles, including untested regulatory pathways, patent challenges and manufacturing issues associated with making such complicated molecules. O...

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FDA issues drug shortage draft guidance

Published on 2012/03/19

FDA announced on 21 February 2012 the release of drug shortage draft guidance for industry in order to increase the supply of critically needed cancer drugs. The announcement follows an Executive Orde...

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FDA approves new suppliers to alleviate cancer drug shortages

Published on 2012/03/16

Two new suppliers of cancer treatments have been approved by FDA to try to alleviate ongoing US drug shortages. FDA has approved the temporary importation of Sun Pharma Global’s Lipodox (pegylate...

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Greece drug shortages

Published on 2012/03/15

A severe drug shortage is threatening to undermine the health and welfare of Greek citizens as prescription drugs and even basic over-the-counter medicines are in increasingly short supply. Even findi...

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GaBI launches GaBI Journal

Published on 2012/02/29

- A new information source for generics and biosimilars - Pro Pharma Communications International proudly announces the launch of GaBI Journal—official Journal of the Generics and Biosimilars Init...

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Oncologists urged to embrace biosimilars to help control spiraling costs of cancer care

Published on 2012/02/24

Oncologists have been urged to embrace biosimilar drug substitution to help control the spiraling costs of cancer care. However, they have been warned that the optimal realisation of such a programme ...

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Obama healthcare budget cuts

Published on 2012/02/24

US President Barack Obama has announced proposals for fiscal year 2013 which aim to cut the US deficit by US$4 trillion over the next decade. However drugmakers have reacted with disappointment to pro...

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