Adalvo has commenced pivotal bioequivalence (BE) studies for generic Binimetinib film coated tablets. It’s a significant milestone in bringing an affordable version of this important oncology therapy to patients in key global markets.
Binimetinib is indicated, in combination with Encorafenib, for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 mutation. Adalvo's development programme covers both 15mg and 45mg strengths, supporting improved posology and flexible dosing.
To explore licensing and partnership opportunities for Binimetinib, or to see our full oncology portfolio of 34 therapies, contact our team today.
Around the world, skin cancer diagnoses are rising. Melanoma may only account for around 1% of all cases, but it is responsible for most skin cancer fatalities.
With the advent of BRAF and MEK targeted inhibitor therapies, including Binimetinib which is a selective MEK1/2 inhibitor, the five-year survival rate for Stage IV metastatic melanoma has risen from under 15% in the mid-2000s to around 35%.
The commercial opportunity is substantial and growing. According to IQVIA data, worldwide sales of Binimetinib exceeded $559 million in 2025, representing a two-year CAGR of 19%.
With a clearly defined IP pathway, Adalvo's generic Binimetinib is well placed to meet growing global demand.
To discuss partnership opportunities for Binimetinib, contact our team.