CHMP’s January Recommendations Include Tofacitinib And Biosimilar Adalimumab
The European Medicines Agency’s Committee for Medicinal Products for Human Use notes also that Sandoz withdrew its application for the biosimilar Zioxtenzo (pegfilgrastim).
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Fourteen medicines that are in the final stages of the evaluation process at the European Medicines Agency should find out this week whether they will be approved for marketing across the EU.
Celgene is finally able to market its mainstay multiple myeloma therapy Revlimid for maintenance use after stem cell transplant, after the FDA further expanded its approved indications. The EU is set to follow suit following a CHMP positive opinion last month.
Amgen’s biosimilar version of the anti-TNF adalimumab has become the first to receive an EU positive opinion but the company has no plans to launch the product this year.