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Prior to this, they undergo an extensive development process, including pre-clinical and clinical trials to confirm both safety and efficacy.

In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany) and Eon Labs (US).

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Pharmacists will need guidance on how to deal with women weighing 75kg or more who are seeking OTC emergency contraceptives, once the European safety review completes, thinks one expert pharmacist.

These changes in manufacturing can induce changes in the product attributes that can have an impact on clinical safety and efficacy.

In Europe, the comparability concept was also of great value for all stakeholders, but the European use of the term “comparable” was also extended to products from different sponsors as per a 2003 guideline.

Demographic, biochemical, clinical and transfusion data were abstracted from the DaVita Clinical Data Warehouse.

Novartis continues to vigorously contest the claims.

Note that each case reported may contain one or multiple suspected ADRs and that the total number of cases represents the total number of reports submitted to EudraVigilance, for a specific marketed biosimilar.

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Several methods have been used to financially incentivize stakeholders to utilize lower priced biosimilars, leading to increases in biosimilars uptake.

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This paper is based on presentations given by Mark McCamish on November 30, 2010 at the 6 th European Antibody Congress in Geneva, Switzerland; on December 8, 2010 at IBC's 8 th Annual International Conference on Antibody Therapeutics held in San Diego, CA and also on the presentation and submission made by the Novartis Group of companies to the FDA Docket on Approval Pathway for Biosimilar and Interchangeable Biological 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.

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NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

Once a biosimilar candidate is shown to be “highly similar” (also a BPCIA statutory requirement), at the analytical level and through biological characterization, the subsequent pre-clinical and clinical studies can be streamlined as a scientific matter.

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Although the Appraisal Committee seeks the views of organisations representing health professionals, patients, carers, manufacturers and government, its advice is independent of any vested interests.

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

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Interestingly, in contrast to the EMA guidelines, Canadian guidelines recommend that sponsors conduct PK studies in the relevant patient population because “results from healthy subjects may not adequately reflect the PK parameters in the patient population where the product is indicated”.

FDA unveiled FY17 user fee rates for drugs and biosimilars that will be lower than those the agency set for FY16.

In compliance with International Financial Reporting Standards (IFRS), Novartis updated its segment financials to reflect these transfers, both for the current and prior year, to aid comparability of year-on-year results.

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Bristol-Myers Squibb Company announced that the FDA has granted priority review for the supplemental Biologics License Application which seeks to expand the use of Opdivo to patients with classical Hodgkin lymphoma after prior therapies.

In order to improve affordability of the medicines in Iran, the government has implemented a direct and not targeted subsidy mechanism for medicines.

The clinical importance of biopharmaceuticals for the management of life threatening diseases is increasing but costs have become a major obstacle to the administration of these medicines, especially in resource limited healthcare systems.

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Our readers are encouraged to submit manuscripts that explore these important aspects of the use of generics and biosimilars.

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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.

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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.

Because of a shortage of data for immunogenicity, the manufacturers of biosimilars that receive EMA approval for indications not studied in regulatory phase 3 trials of the biosimilars (ie, extrapolation indications) must undertake post marketing pharmacovigilance studies of whether clinically significant antibodies occur in these settings, and if these have clinically relevant effects.

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Thus, it is clinical outcome, rather than detected ADA per se, that is the main arbiter for assessing relative immunogenicity for the biosimilarity decision.

In addition, the use of AS patients instead of healthy volunteers is consistent with EMA guidelines for biosimilar MAbs, which recommend conducting PK studies in a “sufficiently sensitive and homogeneous population”.

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Growth products are an indicator of the rejuvenation of the portfolio, and comprise products launched in a key market (EU, US, Japan) in 2011 or later, or products with exclusivity until at least 2020 in key markets.

FDA has proposed using slightly stricter wording, declaring that, in order to be considered a biosimilar, the biological product must be “highly similar to the reference product notwithstanding minor differences in clinically inactive components.

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It is important to emphasize that these guidelines are not legally binding; an applicant may elect to apply alternative approaches, subject to adequate scientific justification.

To achieve highly similar product attributes, the “goal posts” chosen by the biosimilar sponsor, which represent variability of originator product attributes for their design space, become key to the development of a 351(k) biosimilar.

For potential sponsors of all biologics, including biosimilars, considerations must include the research and development costs of the regulatorily-required studies.

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The increase was due to a higher contribution from GSK Consumer Healthcare Holdings, which accounted for USD 88 million in the first quarter of 2016 compared to USD 50 million in prior-year quarter.

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