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Pharmacopeial Convention (USP) endorsed a draft World Health Organization (WHO) proposal to create a unique suffix for biologic drugs, including biosimilars.

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Rates for engineering companies could be about 9 percent lower than what insurers would charge on the individual and smallgroup market, for example, while those for the taxicab industry could be nearly 15 percent higher.

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.

In the United States, it may take four to five years to create a mAb pathway and another two years for the first approval, which puts the earliest a biosimilar mAb could hit the market at 2017.

Unlike chemical drugs, a biologic constantly evolves and can change as the manufacturing process changes, a phenomenon known as drift.

Individuals blowing, and not blowing, the whistle on corruption and malpractice continue to make the headlines.

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To provide additional information that may be useful to investors, including changes in sales volume, we present information about our net sales and various values relating to operating and net income that are adjusted for such foreign currency effects.

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

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Novartis or any of our divisions of the strategic actions announced in January 2016 to focus our divisions, integrate certain functions and leverage our scale; or regarding any potential financial or other impact on Novartis as a result of the creation and operation of NBS; or regarding the potential financial or other impact on Novartis of the transactions with GSK, Lilly or CSL; or regarding potential future sales or earnings of the Novartis Group or any of its divisions; or by discussions of strategy, plans, expectations or intentions.

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Of note, structural testing showed that the biosimilar had less afucosylated antibodies in its product mixture, which results in lower FcRIIIa binding and less in vitro ADCC, one of the hypothesized mechanisms of action for anti-TNF products in inflammatory bowel disease (IBD).

However, issues such as efficacy and safety must be resolved, and clinical trials may be required as well as pharmacovigilance.

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The levelingoff of hospitalizations suggests that Crohns patients are receiving some real longrange benefit from the biologic drugs, Wheaton and Marion said.

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