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Anecdotal stories suggested doping with rHuEpo began as early as the Calgary Winter Games in 1988, followed by rumours of deaths of Dutch cyclists associated with inappropriate use of rHuEpo in 1989 ().

Among 1247 epoetin users for whom the therapeutic plan was revised, 1065 (85.

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

Note from the National Guideline Clearinghouse (NGC): The National Institute for Health and Care Excellence (NICE) commissioned an independent academic centre to perform a systematic literature review on the technology considered in this appraisal and prepare an assessment report.

Post-market commitments apply to biosimilars in Europe just as for originator products.

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Patients and physicians may be reluctant to switch to a biosimilar for small cost savings if the branded product is working.

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Results from EMA-required postapproval risk management plans are immature.

Some EU countries have set biosimilar prices at a fixed percentage below the price of the reference biological.

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Ahmedabad, India Product: Accofil filgrastim Business: Hematology EMAs CHMP issued a positive opinion recommending approval of an MAA from Intas Accord Healthcare Ltd.

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Use of recombinant human erythropoietin for management of anemia in dogs and cats with renal failure.

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It is argued that this will enhance traceability and pharmacovigilance thereby facilitating market uptake.

The National Institute for Health and Care Excellence (NICE) invites 'consultee' and 'commentator' organisations to take part in the appraisal process.

Center for Drug Evaluation and Research, has said it "depends on how confident you can be of the absolute sameness to the innovator product.

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An important distinction between biosimilars and their small-molecule counterparts, generics, is that biosimilars are not necessarily therapeutically equivalent to the reference product.

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EU regulatory practice has been to review the bioanalytical signals detected in comparative clinical studies of biosimilar candidates versus reference products relative to clinically relevant endpoints to assess whether a detected difference in the incidence or magnitude of ADA could have a negative influence on overall clinical benefit and risk.

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Company spun out January 2, 2013, from Abbott Laboratories, whose portfolio included Humira during 2012.

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Use should be restricted to patients with moderate anaemia (e.

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EU, where it was authorized December 2007 for anemia that is causing symptoms in patients with chronic renal failure; anemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions; and to increase the amount of blood patients with moderate anemia can self-donate before surgery.

Sandoz is maintaining its lead in biosimilars; Binocrit is the first approval for biosimilar EPO, although positive opinions have been issued for products from Hexal Biotech Forschungs (another Novartis business unit) and Medice Arzneimittel Putter.

Sandoz, a Novartis division and the global leader in biosimilars, announced recently that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (s.

Guidance on similar medicinal products containing somatropin.

The abbreviations used in the list are explained in the key to annotations in the body of the guide (p33).

Our systematic review follows the process outlined by Cochrane Reviews.

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Quality of original and biosimilar epoetin products.

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It has discretion to find out whether some elements of the regulatory procedure might not be needed.

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Cancer is the second most common cause of death in the country, and the use of biosimilar oncology drugs is growing.

While the approval of biological products for marketing within the EU is under the oversight of the European Medicines Agency (EMA), each EU country has a unique reimbursement system with different incentives in place for the use of biosimilars.

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Discrepancies were resolved by discussion with the involvement of an additional review team member if necessary.

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However, one major difference between biosimilars and generics is that pharmacists do not have the right to "substitute" biosimilars for reference biopharmaceuticals prescribed by a physician.

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Abbreviation: INN, international nonproprietary name.

What are the most attractive target biologics for the development of biosimilars?

National Institute for Health and Care Excellence (NICE).

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Reference lists of included guidelines, systematic reviews, and clinical trials were scrutinised for additional information.

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Our family doctor said that my eyesight might never come back but I decided not to give up.

High dose intravenous iron: a note of caution.

We expect to grow core margin in constant currencies (cc) in line with our full year 2015 guidance, driven by the portfolio transformation, ongoing productivity programs (including effective resource allocation) and Novartis Business Services (NBS).

A generic drug is not worse than brand medicine.

Please, select the items you require by browsing our portal.

The assessment report for this technology appraisal was prepared by Peninsula Technology Assessment Group (PenTAG), University of Exeter Medical School (see the "Availability of Companion Documents" field).

Patients developing Pure Red Cell Aplasia (PRCA) following erythropoietin treatment.

European biosimilars market performance mirrors US legislative progress: slow but steady.

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Comparative efficacy and safety is best demonstrated in head-to-head studies in a study population that is sufficiently sensitive to detect differences between the products, if such differences exist.

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

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The greater affordability of biosimilars may also result in clinical benefits, through earlier and wider appropriate therapy use and release of funding to be used elsewhere in clinical care.

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Countries with emerging biosimilar industries, smaller regulatory agencies, or no regulatory pathway in place for bio similars generally allow extrapolation to indications for reference biologicals that have previously received approval.

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The search strategy is based on the strategy used in the previous multiple technology appraisal (MTA) on this topic by Wilson and colleagues (2007).

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The performance benefits of rHuEpo were noted and inappropriate use by some athletes began ().

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Iban Mayo was reported to have tested positive for rHuEpo during the 2007 Tour and was suspended.

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In particular, management's expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the strategic actions announced in January 2016, the creation and operation of NBS, or the transactions with GSK, Lilly and CSL may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products which commenced in prior years and continues this year; unexpected safety, quality or manufacturing issues; global trends toward health care cost containment, including ongoing pricing pressures, in particular from increased publicity on pharmaceuticals pricing; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, government investigations and intellectual property disputes; general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries; uncertainties regarding future global exchange rates, including the continued increases in value of the US dollar, our reporting currency, against a number of currencies; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare products; uncertainties regarding potential significant breaches of data security or disruptions of our information technology systems; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission.

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All medicines, including biopharmaceuticals in Iran, have their prices set by national authorities, and have to be sold at a fixed price all over the country.

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Although, as in the case of registration of any medicinal product, some degree of uncertainty has been accepted at the time of marketing authorization, a combination of post-marketing data and a heightened level of pharmacovigilance has not revealed any incremental immunogenicity-related risks in respect of the authorized use of biosimilars in the EU.

Depending on the product, this may be an in vitro cell-based assay or a competitive ligand-binding assay.

Abbreviations: ADA, anti-drug antibody; AS, ankylosing spondylitis; NAb, neutralizing antibodies; ELISA, enzyme-linked immunosorbent assay; RIP, radioimmunoprecipitation; CKD, chronic kidney disease; CRF, chronic renal failure; PRCA, antibody-mediated pure red cell aplasia; Neu5Gc, N-glycolyl neuraminic acid; MTX, methotrexate; RA, rheumatoid arthritis; ART, assisted reproductive therapy; FSH, follicle-stimulating hormone; GH, growth hormone; HCP, host cell protein; PK, pharmacokinetics; PD, pharmacodynamics; NHL, non-Hodgkin lymphoma.

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The first biosimilar sponsor for each reference product market may likely need to invest resources educating stakeholders to achieve sufficient market utilization.

The expiration of patents and other intellectual property rights of biological innovators opened the opportunity for biosimilars to enter the market and increase competition among producers of biologicals.

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In Europe the legislation and regulatory guidelines concerning the marketing authorization is the most advanced.

However, one issue that is not addressed is the longer-term impact of switching between multiple products.

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The biosimilar products are Zarzio, Tevagrastim, Ratiograstim and Nivestim in France; Filgrastim-Hexal, Ratiograstim, Biograstim and Nivestim in Germany; Zarzio, Tevagrastim, Ratiograstim and Nivestim in Italy; Ratiograstim and Nivestim in Sweden; and Zarzio, Ratiograstim, Nivestim, Filgrastim Teva, Tevagrastim and Filgrastim Sandoz in the United Kingdom.

However, non-inferiority designs may also be used to demonstrate clinically relevant comparability.

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The whole manufacturing process is regulated by the US Food and Drug Administration (FDA) and other relevant authorities.

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