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The second stage is clinical development which is different for biosimilars compared to novel biologic medicines.

As with other medicines containing an epoetin, side effects during treatment are mainly observed in patients with chronic renal failure and cancer.

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Capitalized product names are trademarks of Janssen Biotech, Inc.

The outcomes from this study were measured during the treatment phase immediately after the switch-over and the concerns with carry-over effects from the first to the second treatment phase cannot be discounted.

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Background: OncoBOS is a prospective, non-interventional study describing Binocrit use in routine practice in France in patients receiving chemotherapy treatment (CT) for solid tumors, lymphoma, or myeloma.

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Another pipeline candidate, PKC412 (midostaurin), was granted Breakthrough Therapy designation by the FDA for newly diagnosed FLT3-mutated acute myeloid leukemia (AML).

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Standard drug indication terms shall consist of a maximum length restricted to 100 characters, with the accompanying code.

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

Interchangeability, immunogenicity and biosimilars.

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Biological Products Subject to Changes in Their Manufacturing Process.

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Nine Republican members of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent a letter to Acting FDA Commissioner Stephen Ostroff urging the agency to release all final guidances on biosimilars.

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In the EU, biosimilars are licensed through a thorough comparability exercise with the reference product, and clinical studies to ensure equivalence of efficacy and safety profiles.

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The biosimilar products are Retacrit and Binocrit in France; Epoetin Alfa Hexal, Silapo, Abseamed, Retacrit and Binocrit in Germany; Abseamed, Retacrit and Binocrit in Italy; Retacrit and Binocrit in Sweden; and Retacrit and Binocrit in the United Kingdom.

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Table 3 Filgrastim biosimilar clinical trials in Europe Abbreviations: PK, pharmacokinetics; PD, pharmacodynamics; IV, intravenous; SC, subcutaneous; EU, European Union.

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FDA approval allows marketing of XM02 for the indication assessed in pivotal trials (prevention of febrile neutropenia after chemotherapy) and it does not require postapproval pharmacovigilance studies.

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However, price erosion and the declining revenues for Diovan monotherapy and a few other drugs will partly offset the revenue growth for the segment.

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D-based Pharmaceutical Association in China (RDPAC) each asked the China Food and Drug Administration (CFDA) to modify and clarify its biosimilars draft guidance.

However, if either local manufacturers or authorities overestimate production capability, there may be a shortage of cheaper, locally manufactured biopharmaceuticals, thus causing a huge economic burden on patients who then have to buy more expensive original brand medicines.

The positive opinion is a formal recommendation by the CHMP to the European Commission which is applicable to all European Union and European Economic Area countries.

Successful cloning of the human EPO gene () allowed for production of recombinant human erythropoietin (rHuEpo), and later the approval to treat patients with anaemia (low Hb levels) in humans.

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The Sandoz centers of excellence are currently working on 900 further development projects, including many in the field of biotechnology.

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Since she had had intestinal surgery, the doctors decided not to give her any anticoagulants.

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PD) comparing the proposed biosimilar, the reference product used in the studies, and the regionally approved reference product.

Por favor, llene su información y la dirección del reparto abajo.

Drug interference is a particularly important limiting factor for detection of ADAs to monoclonal antibodies.

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Revolade is also approved in 45 countries for the treatment of patients with severe aplastic anemia (SAA) who are refractory to other treatments, and in more than 50 countries for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.

At the same time, the division has increased the number of intraocular lens (IOL) projects in its pipeline over the past year, with key pre-loaded and trifocal IOL launches on track for launch in Europe in the second half of 2015, and work underway on a next-generation, potentially best-in-class IOL platform.

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The ongoing trials with HX575 should help elucidate this issue.

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For the main analysis for this systematic review, studies were considered eligible for inclusion if they used a licensed start dose regardless of how they dealt with other criteria stipulated by the license.

Sandoz is the only company with marketing authorization for more than one biosimilar medicine.

Pharmacopeial Convention (USP) endorsed a draft World Health Organization (WHO) proposal to create a unique suffix for biologic drugs, including biosimilars.

European Economic Area, further strengthening its immunology pipeline, which includes investigational biosimilars adalimumab, etanercept and rituximab.

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Do NOT use more than the recommended dose without checking with your doctor.

If originators can prepare global data sets and dossiers, but biosimilar sponsors cannot, this will have a major impact on the supply of the respective products, and the consequent access by patients.

Scala generale Functional Assessment of Cancer Therapy-Anaemia (FACT-An), scala FACT-An per fatigue e scala Cancer Linear Analogue Scale (CLAS).

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Clinical efficacy endpoints were highly similar.

Consultee organisations include national groups representing patients and carers, the bodies representing health professionals, and the manufacturers of the technology under review.

Sandoz has accelerated growth in the US behind a focus on differentiated generics, including the Fougera specialty dermatology business.

For instance, somatropin was launched in France in 1997, nine years later than in Germany and in UK (1988).

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The FDA has to figure that out.

The Marketing Authorisation Holder for this medicinal product is Sandoz GmbH.

Anemia is one of the most common signs of CKD, including HD patients and is mainly caused by relative erythropoietin deficiency.

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It results in different non-proprietary names for biosimilars and their reference drugs.

Hyderabad, India Business: Cancer, Biosimilars Hetero launched Cizumab, a biosimilar of Avastin bevacizumab, in India to treat metastatic colorectal cancer (mCRC).

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Anaemic patients with cancer who are treated with ESAs show evidence of increased frequency of thrombotic events ().

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In addition, Medicare covers most drug expenditures under Part D once catastrophic coverage begins, which also reduces the incentives for drug plans to encourage the use of lower-cost alternatives.

The company provides generics spanning oral solids, gels and patches, injectables, and biosimilars.

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As discussed in a separate review, there are limited additional data from other studies that have evaluated switching from the reference product to the biosimilar product and, less commonly, from the biosimilar to the reference product.

Finally, filgrastim biosimilars show the lowest discount figures in 2008 and 2010 (11% and 8% respectively), but then rise to 32% in 2009.

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Health Canada, Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), March 5, 2010.

Erythropoiesis-stimulating agents (epoetin and darbepoetin) for treating anaemia in people with cancer having chemotherapy (including review of TA142).

Four reviewers independently assessed quality for the newly identified studies (2004 onwards) (see Table 9 in the assessment report).

Specifically, theoretically if a manufacturer of an originator biological decreases its price below the cost of producing the biosimilar, then the biosimilar will leave or not even enter the market.

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The absence of standardized ADA assays, or common positive control antibody reagents to benchmark relative assay sensitivity, precludes reliance on noncomparative clinical data to monitor the longer-term immunogenic potential of the different product versions.

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