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Europe: Omnitrope, Binocrit (epoetin alfa) and Zarzio (filgrastim).

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Hyderabad, India Business: Cancer, Biosimilars Hetero launched Cizumab, a biosimilar of Avastin bevacizumab, in India to treat metastatic colorectal cancer (mCRC).

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Unfortunately, insufficient data were available to exclude a role for heightened immunogenicity in these clinical safety and efficacy observations.

Obviously, these copied biopharmaceuticals cannot be compared to the original brand biopharmaceuticals approved in highly regulated markets.

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Inwieweit ein Wechsel von dem Referenzprodukt auf das Biosimilar möglich ist, ist nicht einheitlich geregelt.

This means that, if a patient has anaemia associated with cancer treatment and the doctor responsible for their care thinks that erythropoiesis-stimulating agents (ESAs) are the right treatment, it should be available for use, in line with NICE's recommendations.

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

Section 7(6) of the requires clinical commissioning groups, National Health Services (NHS) England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication.

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These complex state-of-the-art molecules represent a distinct regulatory class of medicine compared to “traditional”, chemically synthesized medicines.

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Data extraction was carried out by the same reviewers using standardized Cochrane data extraction format.

The company's focus on quality continued to yield results in the first quarter of 2016.

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The results of included studies were qualitatively analysed on the basis of visual inspection of the tabulated extracted data.

Samsung Group, Seoul, South Korea Product: Brenzys etanercept (SB4) Business: Autoimmune Samsung Bioepis Co.

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It is also indicated for the treatment of selected autoimmune disorders, such as psoriasis and rheumatoid arthritis.

In Immunology and Dermatology, Pharmaceuticals is working to expand the indications for Cosentyx beyond psoriasis, with pivotal Phase III studies in psoriatic arthritis (FUTURE 1 and 2) and ankylosing spondylitis (MEASURE 1 and 2) forming the basis for regulatory filings, including in the US and EU, which were completed for both indications in the second quarter of 2015.

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

In some countries drugs have experienced exclusivity times as long as 21 years (Genotropin in Slovenia) and as low as six years (Neupogen in Romania).

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The purpose of this analysis was to provide an annual estimate of market size in terms of monetary values by dividing the market value of biosimilars by that of the total (biosimilars and reference products) market, based on data from 26 countries.

Immune reactions to rHuEpo can lead to antibody-mediated pure red cell aplasia, a serious condition where antibodies to the product cross-react with the endogenous hormone, thereby inactivating it.

Remicade when co-administered with methotrexate” in 19 patients with active RA for over 100 weeks.

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Without extrapolation between indications, the biosimilars pathway has questionable value.

Analyzing complex product attributes over time.

These agents have been tested in preclinical (animal) models and show varying degrees of erythropoiesis stimulation.

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In the US, there has been a heightened interest in ACOs and the use of alternative payment systems, such as fixed bundled payment systems to providers that would cover a group of products and services for a given diagnosis.

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This may influence efficacy and safety, particularly immunogenicity, of the final product.

In NET, it is used for patients with symptoms of carcinoid syndrome from gastro-entero-pancreatic NET as well as for tumor control in patients with advanced NET of the midgut or unknown primary tumor location.

For instance, in addition to the uncertainty regarding regulatory frameworks in nascent biosimilar markets, the first mover may face various legal costs as a result of patent litigation concerning the reference product.

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Common comorbidities included hypertension (88%), coronary disease (40%) and type 2 diabetes (34%).

Then we treated zebrafish embryos with the 3 rhEPOs and we investigated their effect on erythrocytes production with different assays.

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Plasminogen activator inhibitor-1 fused with erythropoietin (EPO) mimetic peptide (EMP) enhances the EPO activity of EMP.

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Abbreviations: ADA, anti-drug antibody; TK, toxicokinetic; hGH, human growth hormone; rhEPO, recombinant human erythropoietin; FSH, follicle-stimulating hormone, C max, maximum drug concentration; AUC, area under the curve; ELISA, enzyme-linked immunosorbent assay; G-CSF, granulocyte-colony stimulating factor.

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We find that multiple factors, including financial incentives, beliefs and behaviours of key stakeholders drive both the entry of biosimilars into the market as well as the extent of its adoption.

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Introduction and study objectives: To describe the development of biosimilars in 24 European Union (EU) Member States, plus Norway and Switzerland, and to identify the key parameters associated with biosimilars market dynamics across EU Member States.

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GSK Consumer Healthcare Holdings (the latter reported as part of income from associated companies).

Other financial income and expense amounted to an expense of USD 41 million in the first quarter of 2016 compared to an income of USD 57 million in the prior-year quarter, mainly due to a negative currency result of USD 59 million in the first quarter of 2016 compared to currency gains of USD 74 million in the prior-year quarter.

ASBM members and staff discussed biosimilars policy with attendees, including the need for the FDA to maintain high standards for safety and efficacy when approving biosimilars.

It is important to note that the figures provided do not refer to the market for all biological medicines, but only to those for which biosimilars were available by the end of 2010.

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Cosentyx (USD 176 million), launched in February 2015, showed strong growth and accelerated uptake in the first quarter.

Our anti-PD1 checkpoint inhibitor (PDR001) started first-in-human trials in April 2015.

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The first myeloid progenitors mature into primitive macrophages and granulocytes, which have the ability to migrate towards the site of a wound and to phagocytose foreign particles by 2 days post fertilization (dpf).

Erythropoietin abuse and erythropoietin gene doping: detection strategies in the genomic era.

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How Will Aché's Biosimilar Portfolio Perform?

These products range from biosimilars, other complex injectables and inhalables, to implants, transdermal patches and complex oral solids.

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 in key markets until at least 2020 (except Sandoz, which includes only products launched in the last 24 months).

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Some unresolved issues remain, most notably concerning the limitation of noninterventional post-marketing surveillance measures to monitor the potential for changes in immunogenicity over the longer term, eg, following introduction of changes in manufacture, formulation, or primary product container.

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Use of biosimilar products is very low in both naïve patients and in those who switch from other reference product epoetins.

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Indication of use and prescribed dosage of epoetins were derived by the therapeutic plans filled in by specialists and linked to drug dispensing records.

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Core studies, especially analytics, represent a fixed cost of biosimilar approval, while region-specific studies represent a variable cost, which the sponsor then weighs against the value of the market within each region.

Disagreements were resolved by discussion, with involvement of a third reviewer.

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Alternative biologics are not biosimilar and have not been approved as biosimilar, and they should be clearly distinguished from approved biosimilars in discussions about the new biosimilars pathway implemented in the US.

Under national tendering, for a given duration of time, either all patients in that country or only new patients will receive the product of the manufacturer who wins the tender.

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Ahmedabad, India Business: Autoimmune, Biosimilars Intas launched Intacept, a biosimilar of autoimmune Enbrel entanercept, in India.

When the Committee meets again it considers any comments submitted on the ACD; then it prepares its final recommendations in a document called the 'final appraisal determination' (FAD).

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