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USD 609 million, mainly related to the acquired assets in Oncology and Ophthalmology, and exceptional divestment gains of USD 326 million (mainly from the divestment of 14 Established Medicines products in Japan).

Biosimilars sind nach dem derzeitigen Wissensstand den gleichwertig und können am Beginn einer Behandlung ebenso eingesetzt werden wie diese.

The EU approval was based on data from the SENSE clinical study - an open label, single arm, multicenter study to evaluate the safety and immunogenicity of HX575 epoetin alfa in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis patients.

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However, the characteristics of biological medicines, particularly the nature of their production process and the need to guarantee patient safety, require a more comprehensive and lengthier development process for authorizing biosimilars than is the case for conventional generics.

Although the approval speed for new biosimilars are getting lower in the two last years (only one new approval since June 2009), more to come with the patent expiries of monoclonal antibodies.

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If after an additional 4 weeks, Hb and reticulocyte count increases still below the levels stated above, discontinue.

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The mean epoetin dose used did not differ significantly between the SEBs and the reference product.

Use of erythropoiesis-stimulating agents among chemotherapy patients with hemoglobin exceeding 12 grams per deciliter.

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The global sales of biopharmaceuticals including biosimilars, biopharmaceutical contract manufacturing, and Glatopa are expected to increase during 1Q16, following increased demand for the drugs.

CIU and SAA with Genentech in the US and shares a portion of the operating income, but does not book US sales.

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Two pharmacokinetic and pharmacodynamics phase 1 studies were done with healthy volunteers and showed similar activity to the biological.

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The impact of immunogenicity-related risks on overall benefit and risk is also considered in relation to extrapolation to therapeutic indications not studied in the preauthorization phase, as well as interchangeability of biosimilar and innovator versions.

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Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2014 Nov 01.

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To date, the only immunogenicity-related issues that have been identified for the biosimilar candidates reviewed in the EU registration process have all occurred in the preapproval setting (summarized in Boxes 1, 2, 4, and 5).

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We find that multiple factors, including financial incentives, beliefs and behaviours of key stakeholders drive both the entry of biosimilars into the market as well as the extent of its adoption.

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Abraham I, Bagalagel M, MacDonald K: Clinical efficacy and safety of XM01, a biosimilar recombinant human erythropoietin, in the management of anemia.

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