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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, including an unexpected failure to obtain necessary government approvals for the announced transaction with CSL, or unexpected delays in obtaining such approvals; the potential that the strategic benefits, synergies or opportunities expected from the transactions with GSK, Lilly or 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; the Company's ability to obtain or maintain proprietary intellectual property protection; unexpected manufacturing or quality issues; global trends toward health care cost containment, including ongoing pricing pressures; 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; 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 the Company's 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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For this systematic review, this was defined as a licensed start dose irrespective of how the study dealt with other criteria stipulated by the license.

This situation is unsustainable and may lead to limited access whereby only the more severely affected patients are treated with these agents when disability might be prevented or limited with earlier intervention.

Zusammenfassend kann festgehalten werden, dass es sich bei Biosimilars zwar um Kopien therapeutischer Proteine handelt, die aber auf Grund der chemischen Unterschiede im der Europäischen Arzneimittelagentur mit eigenen Studien zur Wirksamkeit und Unbedenklichkeit beurteilt und zugelassen werden müssen.

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Exjade is a once-daily dispersible tablet for chronic transfusional iron overload, as well as for chronic iron overload in patients with non-transfusion-dependent thalassemia.

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No unexpected toxic effects, including immunogenicity, were identified with postapproval studies done since 2008.

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The trigger for performing ADA evaluation of samples collected from nonclinical in vivo studies of biosimilar candidates is not specifically described in the draft revision to the overarching guideline.

The evolution of price differentials between biosimilars and reference products is much smaller than for price differentials found in the traditional generics markets.

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.

However, questions remain concerning the evaluation of this epoetin.

This paper will review current and future use of biosimilars in oncology, regulatory aspects of biosimilar approval, and current and future impact of these agents on cancer drug expenditure.

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Biosimilar sponsors can in some cases use comparative analytical and functional studies to bridge between reference products approved in different regions (the reference often being sourced from a single drug substance manufacturing site for worldwide distribution).

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What are the five major classes of biologics that have attracted the attention of biosimilar developers and what are their current market shares?

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The authority to assess and designate pre- and post-manufacturing change biologics as interchangeable was assumed by the FDA under the pre-BPCIA Public Health Service Act (PHSA), and did not entail legislation.

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Business: Autoimmune, Biosimilars Biosimilar company Epirus will reverse-merge with Zalicus in a stock deal.

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It is an integrated pharmaceutical company with three segments, global generics, pharmaceutical services and active ingredients, and proprietary products.

In exercising rats, increased Hb levels resulted in increased in O 2 delivery to the brain and increased muscle fatty acids and glycogen with reduced accumulation of lactate ().

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All biosimilars approved by the FDA via the biosimilars pathway established as part of the Patient Protection and Affordable Care Act (PPAC) are deemed to be highly similar to reference product.

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The term “biosimilar” is used to designate a follow-on biologic that meets extremely high standards for comparability or similarity to the originator biologic drug that is approved for use in the same indications.

The European Group for Blood and Marrow Transplantation, the World Marrow Donor Association, several Italian Societies and Groups, and the Japan Society for Hematopoietic Cell Transplantation advise that biosimilar filgrastim should not be given to healthy donors outside clinical trials or long-term registries.

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Although not an obligatory or standard part of the biosimilarity exercise, regulatory guidance continues to acknowledge the potential of nonclinical data to provide, in the case of molecules having substantial primary amino sequence homology between species, supportive data to detect differences in immunogenic potential associated with identified differences in product-related factors.

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The FDA is developing a pathway for approving biosimilars through an abbreviated BLA (aBLA) process, and the first applications are expected to be for biosimilars already approved in the EU ().

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In the United States (US), the Food and Drug Administration (FDA) is expected to approve its first biosimilar this year.

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As in the EU, each biosimilar will have its own unique set of guidelines.

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Continuous independent variables: pharmaceutical market value, population, gross national income (GNI), price level index of medicines (expresses the price level of a given country relative to the other European countries by dividing the purchasing power parities by the current nominal exchange rate), total expenditure on health as % of GNI, total expenditure on health in absolute terms and government expenditure on health.

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.

The Portfolio declined slightly as generic competition for single-ingredient travoprost products more than offset growth in the fixed-dose combination product.

Binocrit: assemssment of quality, safety and efficacy of biopharmaceuticals.

Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country.

In view of the complexity and cell-based production process, biologicals are inherently more difficult to characterise than standard pharmaceuticals.

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Sandoz, a Novartis division, announced the European Commission has approved a type II variation for the addition of a subcutaneous route of administration in Binocrit's (epoetin alfa) nephrology indication.

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FDA can lead the world in establishing criteria for an interchangeable designation, but even this, as discussed above, should be covered by the concept of comparability, as initiated by the FDA in 1996, adopted by ICH in 2005 and converted for biosimilar use in the EU in 2004.

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As a result, the clinical uptake of EU-approved biosimilar products could be compromised by an unfounded perception that immunogenicity-related risks had not been adequately evaluated or controlled.

Improvement of anemia with deferoxamine in hemodialysis patients with aluminum-induced bone disease.

Commentator organisations include manufacturers of the products with which the technology is being compared, the National Health Service (NHS) Quality Improvement Scotland and research groups working in the area.

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For these patients, once weekly treatment with biosimilar epoetin alfa was shown to be as effective as darbepoetin given every 3 weeks in terms of target Hb levels, while also reducing the need for transfusion iv.

Oncology products acquired from GlaxoSmithKline ( - ) also boosted revenues.

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FDA biosimilar cluster collaborative meeting helps with scientific exchange.

There can be no guarantee that any new products will be approved for sale in any market, or that any new indications will be approved for any existing products in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will achieve any particular revenue levels.

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Samsung, which established Samsung Bioepis, the company's biosimilar arm.

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The authors have been advisors and consultants to manufacturers of both branded biologics and biosimilar products.

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The dominant position of Sandoz is attributed to its biosimilar offerings such as Omnitrope, Binocrit, and Zarzio.

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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Sandoz is seeking approval for the same indication as the reference product.

The approval of biosimilar infliximabs, as the most complex molecules yet approved as biosimilars, illustrates the additional complexity in clinical data burdens and current uncertainty in extrapolation for complex biosimilars.

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One reason is that regulatory agencies, including Europe, the US, Canada, and Australia, require that the biosimilar be compared to a reference product approved in that region.

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IV): one randomized, multiple-dose, parallel group study in 609 renal patients with anemia (correction phase study) and one randomized, multiple-dose crossover study in 313 renal patients with anemia (maintenance study, with an additional follow-up study for long-term safety data).

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This has given an opportunity to biotechnology companies to develop and market biosimilars with a cost benefit of about 20% to 30%.

Lucentis is licensed from Genentech, and Novartis holds the rights to commercialize the product ex-US.

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