HK inno.N said it has signed an exclusive license agreement with Spain’s mAbxience to market the latter’s Prolia (ingredient: denosumab) biosimilar, a preventive treatment for osteoporosis and cancer-related skeletal complications, in Korea.

Under the contract, HK inno.N will exclusively market two types of denosumab biosimilars – 60 mg and 120 mg — from mAbxience, and will apply for domestic approval and proceed with sales.

Denosumab is an antibody treatment that shows a strong bone resorption inhibitory effect by targeting the RANKL protein, which is essential for the survival and function of osteoclasts.

The original products are Amgen’s osteoporosis treatment Prolia (denosumab 60 mg), a treatment to prevent skeletal complications, and XGeva (denosumab 120 mg), a treatment for giant cell tumors of bone in patients with metastatic bone cancer. Both products were launched in Korea in 2016.

According to IQVIA, a drug market research agency, the two products recorded sales of about 120 billion won from October 2021 to September 2022, and their patents will expire in 2025.

With the biosimilar market expected to grow further, HK inno.N plans to quickly seek domestic approval for the denosumab biosimilar to secure a new growth engine.

“Due to excellent efficacy and convenience, the market for denosumab is steadily growing,” HK inno.N CEO Kwak Dal-won said. “Through the introduction of biosimilars, we will provide new treatment options for osteoporosis patients and cancer patients suffering from skeletal complications.”

Meanwhile, mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. It was acquired by Fresenius Kabi last year. The company is conducting clinical trials to confirm the clinical equivalence of its biosimilars against the original denosumab products.