The European Medicines Agency’s advisory group CHMP has adopted a positive opinion backing approval of Pfizer’s (NYSE:PFE) Amsparity (adalimumab), a biosimilar to AbbVie’s (NYSE:ABBV) Humira.
Amsparity will be available in a 40 mg pre-filled syringe and pre-filled pen for adults and a 20 mg pre-filled syringe and 40 mg/0.8 mL vial for pediatric use.
A final decision from the European Commission usually takes ~60 days but has trended closer to 30 days recently.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.