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Biosimilars for inflammatory bowel disease in Norway

Published on 2015/01/12

Europe approved its first biosimilar monoclonal antibody Inflectra/Remsima (infliximab) on 10 September 2013 [1]. The biosimilar is now recommended by the Norwegian Drug Procurement Cooperation (LIS...

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The generics market in Taiwan

Published on 2015/01/08

Taiwan is a growing market for pharmaceuticals and the generics market is becoming more competitive in terms of price and quality, according to a presentation by Yi-Yun Wang [1]. Health care ...

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UK launches generic medicines forum

Published on 2015/01/06

The UK’s drug regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA) and the British Generic Manufacturers Association (BGMA) announced on 16 April 2014 the launch of a ...

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Attitudes towards generics in Turkey

Published on 2015/01/02

Prescribers, pharmacists and patients in Turkey lack knowledge about generics. They may also be misinformed about generics, which can cause hesitation about the use of these drugs, according to Tokl...

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Biosimilar G-CSF safe for mobilization of stem cells

Published on 2014/12/31

A study into the use of granulocyte colony-stimulating factor (G-CSF) biosimilars for peripheral blood haematopoietic stem cell (PBSC) mobilization has found them to be equivalent to the reference G...

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UK court invalidates Herceptin patents

Published on 2014/12/29

A High Court in the UK has overturned two key patents on Roche’s breast cancer blockbuster Herceptin (trastuzumab). The ruling from the London High Court on 10 April 2014 stated that the two pate...

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Free samples increase use of branded drugs

Published on 2014/12/25

The practice of giving free samples to physicians to give out to their patients increases the use of brand-name drugs, according to research published in JAMA Dermatology [1]. Pharmaceutical compan...

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Challenges for the regulation of biosimilars

Published on 2014/12/23

The European Medicines Agency (EMA) was the first agency to issue guidelines for the approval of biosimilars via an abbreviated registration process back in 2006. Since then the agency has developed...

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Cost-cutting in Europe may affect generics sustainability

Published on 2014/12/19

According to a presentation by Mr Victor Lino Mendonça, the continued focus on short-term cost containment measures may lead to an unsustainable market environment for generics and biosimilars in t...

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Results of clinical trials in Europe to be made publicly available

Published on 2014/12/17

It will soon be the law in Europe for all clinical drug trials to be registered and the results reported on a publicly-accessible database. Members of the European Parliament (MEPs) voted on 2 April...

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Positive impact of a value-based approach to health care

Published on 2014/12/15

A study into the use of value-based benefit design (VBBD) for members of an employee health benefits programme demonstrated that such a programme can have a positive impact on adherence and cost out...

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FDA releases bioequivalence guidance for 26 generics

Published on 2014/12/11

On 2 April 2014, the US Food and Drug Administration (FDA) released 26 new draft guidance documents on the bioequivalence requirements for the development of generic drugs in question. The dr...

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