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It's not set in stone yet, but the World Health Organization (WHO) is proposing a voluntary, global naming scheme for biologics, both novel and biosimilar.
CEO: RESUBMISSION BY END OF THIS YEAR
Acelrx Pharmaceuticals Inc. didn't have to wait for its Sunday PDUFA date for Zalviso, but the company also didn't receive the FDA approval it sought and analysts largely expected.

LONDON – The EMA added a eighth product to the roster of biosimilar versions of Amgen Inc.'s Neupogen it has approved, giving the nod to Accofil from Accord Healthcare Ltd., of Haverhill, UK.

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