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Toyama, Japan Business: Biosimilars Lupin and Yoshindo launched YL Biologics, a JV focused on developing biosimilars in Japan.

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

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Entresto (USD 17 million), our breakthrough treatment for chronic heart failure with reduced ejection fraction, saw formulary access improve in the US.

Product: ABP 501 Business: Autoimmune Amgen submitted a BLA to FDA and an MAA to EMA for ABP 501, a biosimilar of Humira adalimumab from AbbVie Inc.

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Sandoz has accelerated growth in the US behind a focus on differentiated generics, including the Fougera specialty dermatology business.

Global sales of Biopharmaceuticals grew 50% (cc) to USD 214 million, benefitting from the launches of Glatopa in June 2015 and Zarxio in September 2015.

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These jurisdictions address the unmet medical need by allowing a follow-on biologic for the same target as the originator molecule to be approved without a demonstration of biosimilarity.

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Sandoz is currently conducting a phase 3 trial of the biosimilar product in the United States.

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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Under reference pricing, the consumer is incentivized to take the lower priced biological, since they are paying out-of-pocket for the difference between the price of the drug they choose and the reference price.

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Preservatives are being investigated for this issue, because after FDA approval, all peginesatide-treated patients received peginesatide from multiple-use vials with preservatives; however, in preapproval trials, peginesatide was given from single-use vials without preservatives.

Concerns about the use of biosimilar granulocyte colony-stimulating factors for the mobilization of stem cells in normal donors: position of the World Marrow Donor Association.

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The “goal posts” of biosimilarity are established by the biosimilar sponsor by their analysis of the distribution of product attributes present in the reference product pre- and post-manufacturing change.

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The Sandoz centers of excellence are currently working on 900 further development projects, including many in the field of biotechnology.

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Attempts to control expression of the gene have been attempted with some success; for example, through use of hypoxia responsive promoters (), or by hybrid promoters responsive to small molecule activators ().

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Abbreviations: AS, ankylosing spondylitis; RA, rheumatoid arthritis; RCT, randomized controlled trial; PK, pharmacokinetics; UC, ulcerative colitis; PMS, post-marketing surveillance; CHF, congestive heart failure; HCP, health care provider.

The Sandoz Institute for Medical Research is founded on the premises of University College, London, United Kingdom.

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Market shares of biosimilars vary considerably by product and country in the EU with those countries that have the highest market shares having the greatest incentives to use low cost products.

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Samsung Group, Seoul, South Korea Product: Biosimilar infliximab (Renflexis) (SB2) Business: Autoimmune Samsung Bioepis Co.

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Even if preauthorization studies were sufficiently sensitive and of adequate duration to detect clinically relevant differences in immunogenicity that might manifest in the longer term, the regulatory process does not impose an obligation on biosimilar product manufacturers to reconfirm equivalent efficacy, safety, and immunogenicity by direct comparison with the reference product to support implementation of changes in the post-marketing lifecycle.

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The real benefit of biosimilars is the introduction of genuine competition into an area that has until now been unhealthily short of it.

This is explained by the apparent need to induce relatively high levels of ADA in order to reduce the circulating level of functional adalimumab to an extent that has an impact on the therapeutic response.

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On the other hand, it would not be feasible to compare switching between different biosimilar product versions in preapproval studies.

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Three biological products had been reference products for at least one biosimilar authorized by the EC.

Cells from or derived from living organisms are used to produce large and complex protein molecules, often by using recombinant technologies.

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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In addition to the approved products, applications for three candidate biosimilar insulin products were withdrawn during the review procedure, and one negative opinion was given in respect of a candidate biosimilar interferon-alfa product.

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In a national tendering system, the government will only pay for tendered product on its formulary, leaving prescribers effectively no choice.

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How quickly this could plug the pending loss of Gleevec sales could be known as early as next year.

The increase was partially offset by a decrease in the core income contribution from Roche to USD 163 million in the first quarter of 2016 due to an adjustment for actual results of the fourth quarter of 2015, compared to USD 171 million in the prior-year quarter.

Arguably, an open-ended designation of “interchangeability” (in a regulatory jurisdiction such as the USA where this implied “substitutability”) would carry an unsustainably heavy burden to confirm continuing biosimilar status, including no difference in clinically relevant immunogenicity following implementation of changes (eg, manufacturing process, formulation, primary container).

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However, competitive sports was affected by illicit use of rHuEpo to enhance performance.

In both studies, the dose of epoetin received was similar with both medicines.

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As we describe later in this paper, a biosimilar sponsor can always decide to file a stand-alone biologics application and follow that pathway, resulting in different data collection.

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No one knows what causes Hodgkin's disease, however several factors have been identified to be associated with Hodgkin's disease.

The Committee concluded that it was reasonable for the Assessment Group to assume in the economic analysis that all erythropoiesis-stimulating agents (ESAs) offer the same effectiveness.

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The limited existing evidence suggests, however, that the relative rates of market share uptake and impact on prices are much lower for biological medicines than for small-molecule medicines.

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