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In 2010, PDMA approved a biosimilar epoetin, although its indication does not include oncology; no oncology biosimilar has yet received PDMA approval.

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Although not proof of rHuEpo doping, testing for haematocrit or Hb levels above a certain value has been explored.

The institute will focus on three immunotherapy areas: stimulating the patient's T-cells, boosting the response rate to current drugs and researching alternative methods of attacking tumors.

Low dose erythropoietin in maintenance haemodialysis: improvement in quality of life and reduction in true cost of haemodialysis.

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One study estimates that between 2007 to 2020, biosimilars will have saved between Euros 11.

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Biosimilar Rituximab: First to Market in the EU?

Marketing Authorisation Application for its proposed biosimilar of Amgen's ( - ) Neulasta (pegfilgrastim) in the EU.

Tribunale amministrativo regionale (TAR) del Lazio and referred five legal questions to the European Court of Justice (ECJ) for a preliminary ruling.

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The FDA has issued four draft biosimilar guidances from 2010 to 2014.

G-CSF), accounting for about half of the global regulated market.

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However, all syringes remained within the 80 to 125% of the stated dose allowed with the European Pharmacopoeia monograph for erythropoietin.

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Celltrion developed a biosimilar infliximab and splits global marketing rights to the product with Hospira, each commercializing the product in different regions.

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When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraph above.

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Recombinant human erythropoietin in anemic patients with end-stage renal disease.

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The quality items assessed included allocation concealment, blinding of participants, investigators and outcome assessors, intention-to-treat analysis, and the completeness of follow-up.

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