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Sandoz has long been a biotechnological competence center within Novartis, and has successfully taken the role as the pioneer and undisputed global leader in the emerging biosimilars market.

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

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Health authorities assume that biosimilars have the potential of lowering prices and hence reducing the pressures on pharmaceutical expenditure, as happens with generics in the small molecule medicines markets.

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In 2013, international regulatory agencies, pharmaceutical manufacturers, and representatives of the Russian Ministry of Health convened a meeting on harmonisation of regulatory standards for Russian biologicals.

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Approval of new drugs, generics and biosimilars, along with the label expansion of existing ones, should bode well for Novartis as it has been facing stiff generic competition for some of its key drugs like Diovan and Gleevec of late.

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Stada Arzneimittel: Joined with Gedeon Richter in announcing plans August 2011 to collaborate on biosimilars for trastuzumab and rituximab.

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Continuing operations also include the results from Oncology assets acquired from GSK and the estimated results from the 36.

The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29.

The first pharmaceutical substance, antipyrine, a fever-controlling agent, is produced.

According to the report, the global biosimilars market consists of key vendors such as Sandoz, Hospira, Teva Pharmaceuticals, STADA, Celltrion, and Biocon.

Nevertheless, non-clinical studies might provide helpful data to justify decisions on formulation of biosimilar candidates, or for investigation of unexpected findings arising from changes in the manufacturing process or in primary container or storage conditions.

There is already evidence of the cost savings being made through adoption of biosimilars.

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