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They are the cornerstone of modern hospital treatment and most typically include intradermal, subcutaneous, intramuscular and intravenous methods of application.
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Operating income was USD 31 million (-78%, -52% cc).
Consumer uptake of biosimilars will depend on both perceptions of safety and quality as well as price incentives.
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Within a year, following reports of fatal “hypersensitivity reactions” in some patients.
The reason for the generation of an immunogenic product is unknown.
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Pharmaceutical companies that hold the marketing authorisation of a medication as well as national medicines regulatory authorities are legally required to submit reports of suspected side effects that occurred in the EEA to EudraVigilance.
These manufacturing methods do not mimic the natural process, indicating that differences between natural and rHuEpo will exist and that these differences can be detected in tests.
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Similarly in humans with primary familial and congenital polycythaemia, the condition is thought to be relatively benign, the disease is non-progressive and the affected subjects have a normal lifespan.
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Comparability data requirements are taken verbatim from the EMA and International Conference on Harmonisation guidelines, and rules on extrapolation abide by the guidelines from the EMA, but do not follow them verbatim.
USD 136 million, -31% cc), which includes Patanol, Pataday and Pazeo, saw sales decline in the first quarter, driven by generic competition, mainly in the US.
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This information has been compiled for use by healthcare practitioners and consumers in the United States.
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The view that new agents could be used because no test has been developed or that detection of some agents is not possible on theoretical grounds is misleading.
However, even this approach is not without critics who point out the possibility of false-positive results, thereby unfairly preventing clean athletes from competing ().
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One aim of gene therapy research has been to deliver EPO genes to humans to treat their anaemia.
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Evaluation of the immuno-stimulatory potential of stopper extractables and leachables by using dendritic cells as readout.
It took time for US consumers to accept generics despite the fact that they share a non-proprietary name with the reference product.
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In addition, NBS continued to scale up the offshoring of transactional services to its five Global Service Centers, and prepare for the rollout of an in-country commercial and medical support platform (expected to start in the second quarter).
Zarzio and Binocrit include US launches.
In the coming years, patents will expire on some major biopharmaceuticals such as interferons and insulins.
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Current Biosimilars Business and Product Portfolio 10.
Indeed, as discussed below, immunogenicity has featured in the risk management plan for all of the biosimilar products approved to date in the EU.
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The greatest structural difference between the innovative epoetin alpha and the biosimilar is its high level of mannose.
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Further comments are invited from everyone taking part.
Possible long-term safety concerns regarding filgrastim have been raised, including activation of autoimmune diseases, and epigenetic or genetic changes that might lead to haematological malignancies.
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The (page 26) shows the expected market penetration of biosimilars.
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Hospira has a strong presence in high potential indications such as anemia and immune-mediated inflammatory diseases.
Hanwha has said it will seek a partner to commercialize HD203 and a biosimilar for Herceptin (trastuzumab).
Generic drugs manufacturers do not need to spend huge amounts on scientific research and development, on extensive clinical trials and marketing campaigns.
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Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives.
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Europe has led in the approval of biosimilars because EMA was the first regulatory authority to be given the mandate to review and approve biologic products that explicitly referred to a previously approved product and because patents on key products expired in Europe sooner than in the US.
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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.
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Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.
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With other agents; for example, ESAs, the effect is indirect and the agent need not be present in the body to derive benefit.
CHRS) said its biosimilar CHS-1420 met the primary endpoint of similarity to reference product Humira adalimumab from AbbVie Inc.
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HCT, saw a continued sales decline in the first quarter due to generic competition.
This is appropriate where comparability is shown, clinical data supports equivalent safety and efficacy to the originator molecule in at least one indication, and a common mechanism of action can be presumed for the clinical effect.
Celltrion announced that it had submitted a biosimilar application in the US for its infliximab biosimilar on August 9, 2014, and a decision is expected by mid-2015.
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Biosimilar ESAs were first seen in Europe in 2007 and not in the US until late 2014 when Hospira applied for FDA approval for its (epoetin zeta).
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Indirect testing of biomarkers suffers from the potential for false-positive results where a natural manipulation; for example, high altitude training, might mimic the effects of exogenous rHuEpo.
In China, about 40% of the biological market is for biosimilars.
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Biologics are large-molecule drugs produced in living organisms and are used to treat some of the most serious life-threatening diseases.
Economic evaluations which only report average cost-effectiveness ratios were only included if the incremental ratios could be easily calculated from the published data).
CIA) with biosimilar epoetin alfa (Binocrit) in patients with colorectal cancer (CC): An interim analysis of an ongoing French national observational study (The OncoBOS study).
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In terms of safety data, 2 cases of pure-red-cell aplasia were linked to the subcutaneous administration of HX 575.
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Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 protein, which supports cancer cell growth and is overexpressed in many patients with CLL.
Such an approach by sponsors and regulators is consistent with all prior regulatory decisions regarding major manufacturing changes of originator products.
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As reported at the time, “What seems to have curtailed use of the drugs more than the FDA warning was a change in the Medicare payment.
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Binocrit è un medicinale biosimilare.
Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist.
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They point out that a “three-year framework was agreed, as of Nov 1, 2012, between the Irish Pharmaceutical Healthcare Association and the Department of Health and the HSE on the supply terms, conditions, and prices of medicines”.
To drive growth with margin expansion, Sandoz is refocusing its business on key geographies and portfolio areas, and streamlining its manufacturing footprint to ensure a fully competitive global production network.
Like the use of comparability to make manufacturing changes, the type and extent of preclinical and clinical studies will be governed by how well the biosimilar sponsor can keep their product within the bounds defined by the “goal posts” of the reference product.
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These products range from biosimilars, other complex injectables and inhalables, to implants, transdermal patches and complex oral solids.
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Professor Joan Rovira, Professor Jaime Espín, Leticia García, and Antonio Olry de Labry, Andalusian School of Public Health, EMINet, January, 2011.
De-duplication was also performed using manual checking.
How much is being spent for developing a biosimilar molecule?
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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.
The following databases were searched: MEDLINE (Ovid); MEDLINE-in-Process (Ovid); EMBASE (Ovid); the Cochrane Library including CENTRAL, the Cochrane Database of Systematic Reviews, DARE, Health Technology Assessment (HTA), National Health Service Economic Evaluation Database (NHS EED) and Health Economic Evaluation Database (HEED); Web of Science (Thomson Reuters); CINAHL (EBSCO); British Nursing Index (ProQuest); Health Management Information Consortium (HMIC) (Ovid); Current Controlled Trials; Clinical Trials.
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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.
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Biosimilars can take more than twice as long to be developed as generics.
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Samsung Group, Seoul, South Korea Product: Biosimilar etanercept (Brenzys, Benepali, SB4) Business: Autoimmune The European Commission approved an MAA from Samsung Bioepis Co.
The reference biological has to have been authorised by the European Union (EU) for at least 10 years.
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EU guidelines clear way for biosimilar antibodies.
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For example, bundling, especially for physician-administered drugs in Medicare Part B and private payers, will incentivize stakeholders to choose the least cost alternative for similar results.
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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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Abbreviations: PK, pharmacokinetics; PD, pharmacodynamics; EMA, European Medicines Agency; FDA, Food and Drug Administration; EU, European Union; GHD, growth hormone deficiency.
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Table provides the chemical denominations and brand names of the biosimilar epoetins marketed in EU.
The primary safety concern for biosimilars, as for all biological medicines, is immunogenicity.
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IGES Institute, The competitive role of biosimilars in the German SHI market for pharmaceuticals, 2010.
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It became possible to defeat the IEF urine test by taking advantage of the rapid elimination of rHuEpo ().
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