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Table 3 Filgrastim biosimilar clinical trials in Europe Abbreviations: PK, pharmacokinetics; PD, pharmacodynamics; IV, intravenous; SC, subcutaneous; EU, European Union.

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For AS, this is the first new treatment advance in 16 years since the development of the current standard of care, anti-tumor necrosis factor (anti-TNF) therapy.

Merck announced its intent to tackle the market last year, and just yesterday said it plans to buy a Colorado biosimilars operation to jump-start its efforts.

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While the approval of biological products for marketing within the EU is under the oversight of the European Medicines Agency (EMA), each EU country has a unique reimbursement system with different incentives in place for the use of biosimilars.

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