Amgen Exec Backs WHO’s ‘Biological Qualifier’, Says First Ones Could Be Issued By End Of 2017
An Amgen executive says that the WHO should press ahead with its “biological qualifier” proposal, and suggests that the first BQs could be issued towards the end of 2017.
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WHO To Pilot ‘Biological Qualifier’ Scheme Despite Protests From Biosimilars Industry
The World Health Organization has decided to pursue its “Biological Qualifier” scheme despite concerns that it may conflict with other traceability systems. Calls by the European biosimilars industry to put the scheme on ice appear to have fallen on deaf ears.
Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira
Company starts 'a new chapter' with the first approval out of its biosimilar pipeline, which happens to be for the biggest drug in the world.
Rare Disease Body Wants EU Legislative Overhaul To Address Orphan Definitions & Incentives
Eurordis has welcomed some parts of the leaked proposals for overhauling the EU medicines legislation, but it has a number of concerns, including the future role of patient representatives if the European Medicines Agency’s committee structure is slimmed down as planned.