Binimetinib

Progression of our generic Binimetinib, based on the reference brand Mektovi, remains on target for a Q3 DCP submission, following expiry of data exclusivity in the EU, and Day-1 launches in key global markets. It’s indicated to treat unresectable or metastatic melanoma with a BRAF V600 mutation in adult patients. Since the 1990s, the world has seen a continual rise in melanoma diagnoses. Metastatic melanoma accounts for around 1% of cases – but is responsible for the vast majority of deaths from skin cancers. The American Cancer Society predicts 234,680 melanoma diagnoses in 2026, a 10.6% increase over previous estimates. Of these, around 112,000 will be invasive cutaneous melanoma, with men accounting for nearly 60% of cases. In Europe, melanoma diagnoses have risen by over 140% since the 1990s, with Germany and the UK showing the highest numbers. Despite increasing case numbers, Cases are rising, but so are survival rates due to the advent of targeted therapies, especially BRAF and MEK inhibitors. These have helped increase the five-year survival rate for metastatic Stage IV melanoma from below 15% in the mid-2000s to around 35% today. The inclusion of Binimetinib for the treatment of unresectable or metastatic melanoma has been given a Category 1 recommendation as a first-line systemic therapy in the US by the National Comprehensive Cancer Network (NCCN). Our generic Binimetinib tablets include 15mg and 45mg strengths for improved posology and flexible dosing. Following the rising melanoma diagnoses, the global market for Binimetinib has shown strong growth. According to IQVIA, global sales reached $509.9 million (MAT) by Q2 2025, representing a two-year CAGR of 23.9%. To explore licensing opportunities for Binimetinib, contact our team today.

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