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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.

This market research report explain current market for erythropoietin drugs in terms of value.

Binocrit should not be used in people who may be hypersensitive (allergic) to epoetin alfa or any of the other ingredients.

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Gain insight into the evolving priorities for HTAs with Xcenda's e-newsletter for HEOR and Market Access professionals.

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Food and Drug Administration advisory on Erythropoiesis-Stimulating Agents (ESAs).

Identification of the renal erythropoietin-producing cells using transgenic mice.

Shacter E, Temple R, Webber K, Winkle H: The FDA's assessment of follow-on protein products: A historical perspective.

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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.

The drug tolerance limit should be validated using the selected positive control antibody reagent according to the recommendations given in United States Pharmacopeia Chapter 1106.

Only your doctor can recommend a course of treatment after checking your health condition.

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Overall, there was no significant difference between the treatment groups for the incidence or type of adverse events.

WADA could be considered delusional in his claim that WADA is catching all users of recombinant EPO.

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This systematic review summarizes the efficacy data comparing epoetin SEBs to the reference epoetins in patients with CKD and provides an overview of the European experience in terms of safety data for epoetin SEBs.

The search filters for RCTs, cost effectiveness studies and quality of life (QoL) studies are different to those used previously.

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Tafinlar has Breakthrough Therapy designation from the FDA for treatment of non-small cell lung cancer (NSCLC) patients with BRAF V600E mutations who have received at least one prior line of platinum-containing chemotherapy, and in July 2015, the combination also received Breakthrough Therapy designation from the FDA for NSCLC patients with BRAF V600E mutations.

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Bezüglich der Biosimilars, die in China, Indien oder Südamerika auf dem Markt sind, bestehen hingegen zum Teil Zweifel bezüglich der Gleichwertigkeit, da dort einfachere Zulassungskriterien gelten.

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Erypo in correcting red blood cell counts in 609 patients over 24 weeks.

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The three in-market products that are leading biosimilars in respective market segments are Omnitrope, Binocrit, and Zarzio.

Cosentyx is also approved in the US, the EU and more than 35 countries for the treatment of adults with AS and PsA, and is under regulatory review in other major markets.

This legal pathway was established in 2004, enabling the authorization between 2006 and December 2013 of biosimilar versions of five different reference products, ie, human growth hormone, filgrastim, erythropoietin-alfa, infliximab, and follitropin-alfa.

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Thus, although the incidence of anti-drug antibody formation in the respective treatment groups was similar, the agency considered that bioanalytical limitations precluded a definitive conclusion on relative immunogenicity of Alpheon compared with Roferon-A.

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The contract prices used for the decision-making in this appraisal represent the latest tenders to London hospitals provided for this appraisal by the Commercial Medicines Unit and the South East England Specialist Pharmacy Services to NICE.

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HBOCs can also increase concentrations of free O 2, which form hydrogen peroxide and peroxynitrite that were thought to be a cause of the tissue injury observed in clinical trials with these agents.

The clinical immunogenicity data, not the nonclinical data, will always be the most relevant arbiter for the biosimilarity assessment regarding the decision to grant approval for marketing.

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France is the first European country to explicitly allow biosimilar substitution.

Although small differences between copied biopharmaceuticals and original brand medicines might not cause significant differences in clinical efficacy, in rare cases these differences might lead to safety problems.

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Sandoz enters the Argentinian market under the name of Labinca.

There are major differences, with unique requirements for biosimilars at all three stages (technical, non-clinical and clinical development).

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Biosimilar filgrastim mobilizes haematopoietic stem cells in healthy volunteer donors with expected efficiency and typical acute adverse effects: interim results of a post-authorization safety study.

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In addition, parameters which could be used in the construction of an independent economic model were identified and noted.

EU regulatory agencies applied a cautious approach in seeking to maximize the potential value of nonclinical data to inform the benefit-risk decision to proceed into clinical studies of these biosimilar candidates.

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Direct costs of ESA treatment were calculated for one patient with cancer undergoing chemotherapy (six cycles at 3-week intervals) with ESA initiated at week 4 and continued for 15 weeks.

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