Adalvo is pleased to announce that the dossier for Ribociclib, based on the reference brand Kisqali®, has reached the finalization stage. The company expects to conduct bioequivalence testing in Q1 2026.
Ribociclib is a CDK4/6 inhibitor used in the treatment of hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced or metastatic breast cancer.
In combination with an aromatase inhibitor, Ribociclib is also indicated for the adjuvant treatment of HR+/HER2– early breast cancer in patients at high risk of recurrence.
Highlighting its clinical relevance, the European Society for Medical Oncology (ESMO) has awarded Ribociclib one of the highest possible scores on the ESMO Magnitude of Clinical Benefit Scale, recognizing its benefit across both early and advanced disease settings.
Adalvo’s development of Ribociclib reflects the company’s continued investment in oncology assets with high unmet need and limited generic competition. According to IQVIA, global sales of Ribociclib reached $3.3 billion in 2024, with a three-year CAGR of 54%, demonstrating strong and sustained market growth.
With a clear regulatory and IP pathway, Adalvo is targeting a Day-1 launch in priority markets upon loss of exclusivity.
Ribociclib further strengthens Adalvo’s differentiated oncology portfolio, developed to deliver clinically meaningful, partner-ready assets in complex therapeutic areas.
To explore licensing or commercial opportunities within Adalvo’s oncology portfolio, please contact us.