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Adalvo Advances Pilot BE Study for Apalutamide, With A Targeted Day 1 Launch

09 May 2025

Adalvo has progressed into the pilot BE study phase for Apalutamide, with results expected by June 2025, marking a key step towards submission and Day 1 launch readiness in major markets. 

Based on the reference brand Erleada, Apalutamide is an oral treatment available in 60mg and 240mg film-coated tablets, used in the management of non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). These conditions represent a growing therapeutic area with high clinical relevance and patient need. 

The product recorded global MAT sales of $4 billion in 2024, with a 36% 3Y CAGR (IQVIA), reflecting sustained commercial growth and market relevance. 

Adalvo’s program is supported by a clear regulatory strategy and a focused development plan, reinforcing its commitment to first-to-market execution in high-value therapeutic categories. 

By accelerating the development of complex oncology generics like Apalutamide, Adalvo strengthens its position as a partner of choice for science-driven, strategically aligned product launches. 

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