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It was also planned that if sufficient RCTs were identified, an attempt would be made to assess funnel plot asymmetry due to small study effect, as this may be indicative of publication bias.

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Scientific principles suggest that using a single global reference product is reasonable, provided that it is proven comparable to the same product labeled in other major regions.

It is also the case that our legislators, generally being ignorant of things medical and scientific, will pass stupid laws.

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Biosimilars are seen as a cost-effective alternative to the high-priced branded biologics, offering cost advantages to both payers and patients.

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WEDNESDAY, Dec. 21, 2011 HealthDay News As the obesity epidemic spreads around the world more people are suffering from acid reflux, likely increasing the number of those who will develop esophageal cancer, a new study suggests.

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By engaging today in advocating and implementing the highly similar standard for mAb biosimilars and working with EU on their published draft guidelines, the FDA can rejoin EMA in leading the oversight of all biologics for a global patient need.

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Bei Biosimilars ist die Situation anders, da es sich um Arzneistoffe handelt, die sich in der Herstellung und Wahl des Expressionssystem vom Originalprotein unterscheiden.

The foundation of the biosimilar development process is a concept called "Quality by Design": a robust, lengthy and iterative process that ensures our biosimilars are highly similar to the reference biologic medicine.

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However, it recognised that there would be minimal effect on incremental cost-effectiveness ratios (ICERs) given that the adverse reactions in the studies were rare.

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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