Swedish pharmaceutical company Newbury Pharmaceuticals AB (STO:NEWBRY) announced on Friday that it has obtained Marketing Authorization in Denmark for Palbociclib Newbury tablets, marking the first approval within a Scandinavian registration procedure.

Approvals in Sweden and Norway are expected following completion of national regulatory reviews.

A generic version of Ibrance, Palbociclib Newbury is a selective CDK4 and CDK6 inhibitor indicated for the treatment of HR-positive and HER2-negative breast cancer. The Scandinavian market for the product is estimated at EUR21m annually, according to DLMI Nordic Pharma Insights.

Newbury plans to launch the product in relevant markets once regulatory exclusivities and patent constraints allow.