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The EMA has also accepted Sandoz's regulatory submission for biosimilar Neulasta, marking the fifth of 10 planned biosimilar filings through 2017.

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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EU guidelines clear way for biosimilar antibodies.

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Guidances developed by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and WHO set out principles for showing similarities between biosimilars and reference products ().

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Safety monitoring will be product-specific because pharmaceutical companies periodically make manufacturing-related changes and small changes can affect safety or efficacy.

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Report Details Producers of biosimilars - how to assess products, developments, and revenue prospects What does the future hold for makers of biosimilar drugs?