Adalvo has confirmed positive results from its bioequivalence (BE) study for its non-infringing difficult-to-develop generic Apalutamide tablets, conducted under both fasting and fed conditions. The study results confirm bioequivalence with the reference product, marking a significant regulatory milestone and keeping the programme firmly on track for filing across early and wider markets, including Europe.
With the BE studies successfully completed, Adalvo will continue the full development programme and dossier preparation for the upcoming European DCP filing on Day-1 of Data Exclusivity expiry on 16 January 2027 and earlier in Early Markets.
Simon Kukec, SVP, Global R&D and Clinical commented: “Achieving positive BE results in both conditions is a meaningful technical milestone, and one that reflects the depth of formulation expertise we've built at Adalvo. I'm proud of what the R&D team has delivered here — this is exactly the kind of difficult-to-develop programme that defines who we are and why our partners trust us to execute.”
Developed as a generic of Erleada®, Apalutamide is one of the most commercially successful prostate cancer therapies of its generation. It is indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC), in combination with androgen deprivation therapy (ADT).
Prostate cancer is the most diagnosed cancer in men. An April 2024 study by The Lancet found that global case numbers are set to double by 2040, reaching approximately 2.9 million annually — meaning the demand for effective, accessible treatments will grow in step.
Apalutamide's strong clinical profile — including a 35% reduction in mortality risk and 52% delay in disease progression versus ADT alone — underpins both its first-line guideline status and its sustained commercial performance.
Adalvo is developing Apalutamide in both 60 mg and 240 mg strengths, supporting prescriber flexibility and compatibility with country-specific product strategies.
According to IQVIA, global sales of Apalutamide reached approximately $5.2 billion in 2025, representing a three-year CAGR of 31%, reflecting both its clinical importance and strong commercial demand.
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