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Health authorities assume that biosimilars have the potential of lowering prices and hence reducing the pressures on pharmaceutical expenditure, as happens with generics in the small molecule medicines markets.

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Those guidances, released last year, left numerous questions unanswered: How similar should the near-copies be to their innovator drugs?

Any enquiries from NHS organisations about the contract prices used in this appraisal should be directed to the Commercial Medicines Unit and the South East England Specialist Pharmacy Services.

Excluded from discontinued operations are certain intellectual property rights and related other revenues of the Vaccines Division, which are retained by Novartis and are now reported under Corporate activities.

Ferrlecit-treated patients were considered to have completed the study per protocol if they received at least eight Ferrlecit doses of either 62.

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All this has already been accomplished by the original manufacturer, and was subsequently reflected in the brand-name drug price.

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Sandoz included all clinical trials from the EMA submission in the data package submitted to Health Canada.

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Manufacturers of reference biologicals request that biosimilars marketed in the USA have unique INNs to help with adverse event tracking and reporting.

The ongoing trials with HX575 should help elucidate this issue.

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Prvi inteferon koji je odobren od strane FDA za lijecenje hronicnog hepatitisa C (1991) je Intron A (IFN alfa 2b), sintetiziran u firmi Shering-Plough Corporation.

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Autosomal dominant erythrocytosis caused by increased sensitivity to erythropoietin.

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

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While significant progress has been made in the development, approval, and commercialization of biosimilars in the highly regulated markets, it is not clear whether the regulatory environment is conducive to significant abbreviation in biosimilar development.

Title How Much are Biosimilars Used in Southern Italy?

RBCs avoid this problem because of cellular enzymes (catalase and superoxide dismutase) that destroy hydrogen peroxide.

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To address its potential impact, we conducted a targeted literature review using PubMed and Google Scholar to examine the development of the biosimilar medicines market and the impact of product naming, if any, in the EU, Australia, and Japan, with a specific focus on the varieties of naming.

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PD effects for IV and SC administration of biosimilar epoetin and Eprex.

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It must not be used in patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin, patients with hypertension (high blood pressure) that is not controlled, patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke, or patients who cannot receive medicines to prevent blood clots.

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Further stimulation of colony-forming unit erythroid with eEpo results in synthesis of Hb and differentiation into proerythroblasts, and finally, erythroblasts.

In addition, biosimilars foster competition, which reduces overall costs and leads to savings for healthcare systems, increased patient access, and freed-up funds that may be used to develop innovative therapies.

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US and Australia as well, but not through the biosimilar regulatory route.

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However, it recognised that there would be minimal effect on incremental cost-effectiveness ratios (ICERs) given that the adverse reactions in the studies were rare.

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