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Adalvo Announces Successful BE Outcome for Palbociclib Film-Coated Tablets

28 July 2022

We are pleased to announce that we have now completed our Pilot BE program for Palbociclib Film-coated Tablets, which is being developed in collaboration with our oncology specialty, sister company, forming part of the Aztiq group.

Our product is being developed based on the reference brand IBRANCE, which is indicated in the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer and is the first FDA approved medication in its class.  The brand sold approximately $6.1bn globally in 2021, with a 3Y CAGR of 4%, according to IQVIA. 

Based on this positive progress, we will proceed with submission batch manufacturing and Pivotal studies.

Disclaimer: Palbociclib Film-coated Tablets which is subject to patent protection is currently not offered or made available in countries where patents are in force.