News

Malaysia objects to patent terms in free trade agreement

Published on 2012/10/19

Once again, the issue of patent protection and the periods of exclusivity given to originator pharmaceuticals (both small molecule and biological) has raised its ugly head in the negotiations for the ...

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European uptake of biosimilars

Published on 2012/10/17

Despite the fact that Europe accounts for 80% of global spending on biosimilars, uptake varies significantly between different countries. This variation is mostly attributed to differences in the heal...

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Asian companies venture into biosimilars for kidney failure

Published on 2012/10/15

Malaysia-based Chemical Company of Malaysia Berhad (CCM) wholly-owned subsidiary CCM Duopharma Biotech Berhad and Korea-based biotechnology company PanGen Biotech announced on 19 June 2012 that the co...

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Testing for unwanted immunogenicity from biologicals

Published on 2012/10/12

Immunogenicity caused by biologicals, both originator and biosimilar, is an important issue that was raised by Dr Wadhwa from the National Institute for Biological Standards and Control. Most biologi...

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Biosimilar monoclonal antibody approved in Korea

Published on 2012/10/10

South Korean biotechnology company Celltrion announced on 23 July 2012 that the Korean Food and Drug Administration (KFDA) had approved its first monoclonal antibody, Remsima. The drug is a biosimila...

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Australia moves towards pricing policy for biosimilars

Published on 2012/10/08

The Australian Pharmaceuticals Industry Council (PIC) has agreed to a broad strategy for the pricing of biosimilars so as to encourage the development and entry of biosimilars into the market place. ...

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Deal struck over development of Herceptin biosimilar

Published on 2012/10/05

Netherlands-based biopharmaceutical company Synthon announced on 18 July 2012 that it has entered into a global licensing agreement with Amgen and Watson Pharmaceuticals for the clinical development a...

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FDA urged to exclude plasma protein therapies from biosimilar pathway

Published on 2012/10/03

FDA is being lobbied by patient and industry groups to exclude plasma protein therapies from its pathway for the approval of biosimilars. FDA has a mandate to create a new abbreviated process for the ...

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Biosimilar infliximab equivalence proven in phase III trial

Published on 2012/10/01

Results from a phase III trial of biosimilar infliximab have proven the equivalence of South Korean biotechnology company Celltrion’s biosimilar (CT-P13) and the reference product – Johnson & ...

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US supreme court ruling means biosimilars pathway safe

Published on 2012/09/28

On 28 June 2012 the US Supreme Court ruled in favour of the bulk of the Affordable Care Act, meaning that the biosimilars pathway, which is part of the act, is now also safe. The Supreme Court had be...

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Mexican guidelines for biocomparables

Published on 2012/09/26

The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). The agency is a decentralised organ of the Department of Health ...

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US$67 billion worth of biosimilar patents expiring before 2020

Published on 2012/09/24

Twelve biological products with global sales of more than US$67 billion will be exposed to biosimilar competition by 2020, with Enbrel (etanercept) whose US patent has been extended until 2028, scorin...

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