Daijiworld Media Network – Hyderabad

Hyderabad, Sep 23: Pharmaceutical major Aurobindo Pharma is set to enter the global market for osteoporosis and cancer-related bone treatments with its biosimilar version of Denosumab, following successful Phase 3 clinical trial results.

Satakarni Makkapati, CEO of Aurobindo Pharma’s biologics, vaccines, and peptides business, said the company is preparing regulatory filings in key Western markets, aiming to capture a significant share of a global market currently valued at $7 billion.

“Denosumab is a monoclonal antibody used primarily to treat osteoporosis and bone metastasis from cancer. The drug has strong market potential, and with biosimilar entrants expected from late 2025, we plan regulatory filings in the US, EU, and other key markets from January 2026,” Makkapati said in an interview with NDTV Profit.

He expressed confidence in a swift European approval process, anticipating clearance from the UK and Health Canada within 9–10 months, with approval expected by the end of 2026. The US approval is projected by 2027.

According to Makkapati, the current Denosumab market is valued at $2.2 billion in Europe and $5 billion in the US. He expects biosimilars to capture 30–50% of the innovator market by 2030, translating to initial sales of $1.5–1.6 billion, potentially growing to $3–4 billion, distributed among five to six major players.

However, he cautioned about intense competition and accelerated price erosion, noting that some early market entrants may eventually exit. “We need to see how many of these early entrants would be the last man standing,” he concluded.