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In March 2010, the Patient Protection and Affordable Care Act (PPAC Act) was signed into law establishing an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to an FDA-approved biological product.
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In addition to the matters described above, there have been other developments in the other legal matters described in Note 20 to the consolidated financial statements contained in our annual report for the year ended December 31, 2015.
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In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Improvements in quality of life following treatment with r-HuEPO in anemic hemodialysis patients.
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Administration and Other expense include expenses related to setup costs for Novartis Business Services; Other income includes an income related to the portfolio transformation, other restructuring income and gains from product divestments; Other income and Other expense also include net legal settlements.
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Data extraction for these studies was checked by a second reviewer.
Write back if you have additional questions or concerns about your fatigue or anemia.
Notes: Balancing pros and cons for each pathway in the United States, sponsors have to weigh the risks and benefits of each pathway for each product to decide which path will present the greatest potential return on investment in each market.
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Eporatio (Epoetin Theta): A True Biosimilar?
The EMA advises, but does not mandate, that biosimilars should share INN names with their reference drugs; unique names for the active substance are also assigned.
More approvals are expected and as a result, many stakeholders are debating the regulatory frameworks around the introduction of biosimilars, including naming conventions for biosimilars.
The performance benefits of rHuEpo were noted and inappropriate use by some athletes began ().
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Venezuela Venezuela drafted guidelines for biosimilars in 2012, but the country has yet to formalise any regulation.
This was implicated as a causal factor for induction of neutralizing antibodies in two patients with chronic kidney disease following subcutaneous administration of a biosimilar erythropoietin product.
The creation of an FDA approval pathway for biosimilars is complex and fraught with hazard.
Considerations must be made to avoid inappropriate sanctioning of athletes who, through genetics or physiology, test positive for doping.
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Some other terms used when describing Hodgkin's disease are resistant or progressive disease.
This work is published and licensed by Dove Medical Press Limited.
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The reason for the generation of an immunogenic product is unknown.
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Tbo-filgrastim, a product approved as a biosimilar in Europe, and in 2013 as a new biological in the USA, is discounted by 20% of the price of reference filgrastim.
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With some agents; for example, RBC transfusions, plasma volume expanders, artificial blood or O 2 carriers, the agent is present in the body during the competition.
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The focus of biosimilar development will shift from medicines used in the supportive care setting to agents that provide life-saving or life-extending benefits such as monoclonal antibodies (mAbs).
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EPOR, and to induce signal transduction and transcription events highly similar to rHuEPO (Green et al.
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Offsetting factors included valuation gains on commodities of USD 14 million in the first quarter of 2016 compared to a loss of USD 1 million in the prior-year quarter and monetary losses from hyperinflation accounting of USD 20 million in the prior-year quarter.
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In 2010, the patents of many major biopharmaceuticals will start to expire, paving the way for biosimilar competition.
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The clinical expert highlighted that erythropoiesis-stimulating agents (ESAs) lower the need for transfusions, but are not widely used in the UK for treating anaemia in people having chemotherapy.
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EU Member States considering the following variables: date of market entry, unit sales and prices (estimated using official prices) of existing biosimilars and their respective reference products.
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We provide a detailed overview of biosimilar uptake and the impact of nomenclature from key perspectives in the EU (examining Germany and Norway as cases of special interest representing more advanced markets in the EU), Australia and Japan.
Xolair as a treatment for chronic spontaneous urticaria is addressed earlier in the Immunology and Dermatology section.
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The FDA's approval of biosimilars is critical to facilitating patient access to high-quality biologic medicines and will allow society to afford the truly innovative molecules currently in the global biopharmaceutical industry's pipeline.
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Available evidence indicates that biosimilars offer a safe and effective alternative to originator biological therapies.
Although some differences were detected in the apparent magnitude of the treatment-emergent antibody response to particular products, overall the results from the nonclinical immunogenicity evaluation were deemed not to have been instructive for the biosimilarity assessment: aside from the equivocal validity of extrapolating from an irrelevant immunological context to humans, imprecision associated with high biological variability and small group sizes makes data interpretation extremely difficult; in addition, differences in ADA assay sensitivity preclude a predefinition of meaningful differences based on historical data for the product class.
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Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced results from the EGALITY trial in which the primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 was met.
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Profiles of 95 biosimilar developers, their products in the market and their product pipeline.
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Nor can there be any guarantee that filgrastim, or other biosimilar products, will achieve any particular levels of revenue in the future.
In the first quarter, we also completed the integration of development for the Ophthalmic Pharmaceuticals franchise, which previously was managed by the Alcon Division.
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Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-α (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study.
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Arguably, an open-ended designation of “interchangeability” (in a regulatory jurisdiction such as the USA where this implied “substitutability”) would carry an unsustainably heavy burden to confirm continuing biosimilar status, including no difference in clinically relevant immunogenicity following implementation of changes (eg, manufacturing process, formulation, primary container).
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Evaluate Iron status prior to and during treatment and administer iron supplementation if necessary.
Cosentyx is the only fully human monoclonal antibody that selectively neutralizes circulating interleukin-17A (IL-17A) and is approved to treat psoriasis, ankylosing spondylitis (AS) and psoriatic arthritis (PsA).
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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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In compliance with IFRS, Novartis updated its segment financials to reflect the new divisional structure announced on January 27, 2016, to aid comparability of year-on-year results.
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In addition to driving innovation in-house, NIBR manages a robust network of alliances, including more than 300 collaborations with academic institutions and more than 100 collaborations with biotech and pharmaceutical organizations (270 including those managed by the Pharmaceuticals Division).
Occasionally, drugs are used before safety tests have been completed, and athletes are taking great risks because the safety issues are not completely understood.
Access for even the current patients treated with biologics can become restricted due to costs.
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