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Category-based guidelines are valuable in the development of standards for biologics, since the complexity of structure and glycosylation differs greatly across categories of biologic products.

How should biosimilars be named and labeled?

The outcome of an ongoing inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK is still pending.

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PD parameters between the biosimilar and the reference product.

Pasco I: a 1-year long post-registration safety study on biosimilar epoetin zeta across Germany, Spain, Italy, and the United Kingdom.

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Whereas EMA, faced with the same data, decided that these differences did not preclude extrapolation, Health Canada felt that clinical differences between the biosimilar and reference product for these indications (ie, IBDs), given that ADCC may represent an important MOA in IBDs (but not other indications), could not be ruled out.

The EC approved this oral formulation under the name Exjade film-coated tablets for the same indications as Exjade dispersible tablets.

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.

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Please, keep in mind that the time of delivery specified here is the estimated delivery time which is true for most cases, but cannot be guaranteed due to the probability of force majeure events described below.

Projections are likely to be most accurate for biosimilar epoetins, since these have been available in Europe for several years and therefore have known market trends.

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During transit through the secretory apparatus, the 27 amino-acid signal peptide and C-terminal arginine are removed, and carbohydrate chains are added to three N-linked glycosylation sites and the one O-linked glycosylation site.

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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What are the top ten biologics that have become the focus of biosimilar developers?

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First biosimilars introduced in 2008.

Novartis, the interim name of filgrastim-sndz; thus, initially the FDA has decided on different non-proprietary names.

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In general, the post-translational modification profile should be within the range demonstrated for the reference product, although there may be exceptions in the case of identified safety risks for the originator (eg, for cetuximab).

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Cosentyx(USD 176 million), which was launched in the first quarter of 2015 as the first fully human IL-17A inhibitor for the treatment of psoriasis, continued to show strong growth and accelerated uptake in the first quarter of 2016, benefitting from its three approved indications (psoriasis, ankylosing spondylitis and psoriatic arthritis).

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This process is repeated until highly similar product attributes are achieved.

Total Group net income and EPS include in the prior year the impact of the exceptional divestment gains and the operating results of the discontinued operations.

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USD 609 million, mainly related to the acquired assets in Oncology and Ophthalmology, and exceptional divestment gains of USD 326 million (mainly from the divestment of 14 Established Medicines products in Japan).

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Notable features for the clinical immunogenicity evaluation of these biosimilar candidates are summarized in the next paragraph.

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The abbreviations used in the list are explained in the key to annotations in the body of the guide (p33).

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