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CHMP’s January Recommendations Include Tofacitinib And Biosimilar Adalimumab

 
• By John Davis

The European Medicines Agency’s Committee for Medicinal Products for Human Use notes also that Sandoz withdrew its application for the biosimilar Zioxtenzo (pegfilgrastim).

Recommendation

The Committee for Medicinal Products for Human Use (CHMP) carries out scientific assessments for the European Medicines Agency and recommends whether medicines submitted through the centralized procedure should be granted marketing authorizations. The committee also prepares scientific and regulatory guidelines and monitors adverse drug reaction reports.

Once approved by the European Commission, a centralized marketing authorization is valid in all EU member states as well as in Iceland, Liechtenstein and Norway. Here are the highlights of...

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