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Therefore, effective pharmacovigilance programmes are essential to evaluate whether the safety and efficacy profiles of these locally produced biopharmaceuticals are different from those of either the original brand biopharmaceuticals or their biosimilar versions.

Our collaboration and license agreement with Incyte has been amended to grant Novartis exclusive research, development and commercialization rights for Jakavi in graft-versus-host disease (GVHD) outside the US.

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They are now working on adapting the device so it can also be used to measure chemical or mechanical changes that occur in the brain following drug treatment.

Europe are estimated to be treated for anemia with ESAs such as Binocrit and worldwide annual ESA sales are estimated at more than USD 13 billion, with 20% of sales in Europe1.

Currently the national health insurance system is the main tool in Iran for improving the affordability of medicines.

Abraham I, MacDonald K: Clinical safety of biosimilar recombinant human erythropoietins.

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DRA is caused by buildup of a protein in the blood that is unable to cross the dialysis membrane.

Biosimilars in the EU are usually priced 15 percent to 30 percent below their referenced products, but they have achieved little market share because of their lack of interchangeability.

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Despite the introduction of biosimilars into world pharmaceutical markets many years ago some countries still lack regulations for registration of these medicines.

Volume Uptake of Biosimilar G-CSF in Standard Units vs.

Studies show, however, that when people who report being allergic to penicillin are tested for the allergy, nearly 90 are not allergic, and are able to take the medicine just fine.

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European Union (EU), and contains a similar active substance to the reference medicine.

Regulatory biosimilar guidelines (2009) are based on guidelines from the EMA, WHO, and Japan.

The Australian Government adopted a biosimilar approval pathway in 2008, based on the existing system developed in the EU.

Erythropoiesis-stimulating agents (ESAs) have been shown to steadily increase haemoglobin (Hb) levels, reduce the need for transfusions and improve overall quality of life in patients with chemotherapy-induced anaemia (CIA) iii.

There is however another important difference: the price.

Spiller believes one of the big challenges is managing medicationmeasurement errors.

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Guideline on Similar Biological Medicinal Products.

Sandoz is focused on extending its lead in differentiated generics, and driving growth with margin expansion to support continued investment in innovation.

The types of agents or procedures used can be divided into several categories according to their point of intervention.

Overall, it is still unclear whether in vitro immunogenicity risk mitigation methods could contribute incremental value for early screening of biosimilar candidates, ie, to detect differences that are not within the sensitivity range of state-of-the-art physicochemical methods.

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Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected.

To put it simply: Biosimilars are large, complex molecules (mostly proteins) produced by living organisms, which are highly sensitive to manufacturing changes; generics are small molecules, produced by chemical synthesis, which are usually very stable.

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Hospira: Biosimilar in active development.

Finally, filgrastim biosimilars show the lowest discount figures in 2008 and 2010 (11% and 8% respectively), but then rise to 32% in 2009.

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Many biosimilar sponsors have relied on the same basic data package with additional such bridging studies as necessary.

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This product is subject to generic competition, and in various countries, Sandoz markets generic versions of Voltaren.

If immune responses to reference products are rare, then a premarket study powered to detect major differences in immune responses between products and a postmarket study designed to detect more subtle immunogenicity differences will suffice.

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PD effects for IV and SC administration of biosimilar epoetin and Eprex.

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The Committee was concerned that the Assessment Group did not include disutilities associated with adverse reactions in the QALY calculation given that most adverse reactions occurred more frequently in the ESA arms.

In addition, a combination of in vitro and ex vivo analyses was used to assess the potential of aggregates of a human monoclonal antibody to influence the interaction between innate and adaptive immune responses.

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Supporting our Oncology strategy, for example, NIBR has a broad pipeline with drug candidates covering most oncogenic pathways.

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Those near the end of life received 61 hours of help per week compared to 35 hours of help per week for older adults who werent at the end of life.

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Abuse of medicines and procedures, and manipulation of the genome to enhance performance in competitive sport are widely frowned upon because of the damage to the athletes, the sport and the manufacturers who make them.

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Although the approval speed for new biosimilars are getting lower in the two last years (only one new approval since June 2009), more to come with the patent expiries of monoclonal antibodies.

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Biosimilars: what they are and their use in oncology.

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To address its potential impact, we conducted a targeted literature review using PubMed and Google Scholar to examine the development of the biosimilar medicines market and the impact of product naming, if any, in the EU, Australia, and Japan, with a specific focus on the varieties of naming.

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On April 26, 2012, announces results of ongoing tests showing that its immunomodulator molecule lichenase (LicKM) enhances vaccine antigens when produced as fusions to LicKM.

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Nonetheless, with the US as the largest single market now in play and FDA reviewing at least four biosimilar applications, much is expected to be learned in 2015 as to the feasibility of global biosimilar product development.

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Even though biosimilar sponsors may find it difficult to predict what a demonstration of biosimilarity looks like, it is important to acknowledge that regulatory agencies are experienced at making similar comparability determinations when they approve manufacturing process changes for biologic products.

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These case studies also highlight some biosimilar sponsor latitude as reflected in the varying clinical data packages submitted to the same regulatory agency for biosimilars to the same reference product.

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Samples from clinical studies should be evaluated in a blinded manner using a hierarchical testing scheme, following the recommendations applicable in the regulatory guidance for biopharmaceutical products.

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Depending on the extent that product attributes of the biosimilar overlap with those of the originator product, preclinical and clinical development can be abbreviated compared to developing a novel biologic.

This is an approach that has been tried, tested and proved to work in practice.

In both trials, treatment allocation was randomised and openlabel but endpoint assessment was blinded.

Although it is too early to comment on how actual or perceived differences in immunogenicity might play out in the longer term, there would seem to be an essential role for post-marketing immunogenicity data that are comparable in nature, ie, using standardized methodology for monitoring patient populations exposed to different product versions.

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BACKGROUND: The conventional antiviral treatment of chronic hepatitis related to hepatitis C virus (HCV) often leads to anemia.

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