On 4 September 2026, Daily Pharm Korea reported that South Korean-based Shin Poong Pharm has received Korean regulatory approval for Denovon™, biosimilar to Amgen’s Prolia® (denosumab). The biosimilar is anticipated to launch at the end of 2026 following reimbursement and pricing reviews.
Shin Poong has the exclusive Korean development and commercialisation rights to Denovon™ under a 2021 agreement with India’s Enzene Biosciences (an Alkem subsidiary). Denovon™ is a 60 mg/1 mL prefilled syringe indicated for the treatment of osteoporosis in postmenopausal individuals, glucocorticoid-induced osteoporosis, and bone loss associated with certain prostate and breast cancers.
Denovan™ joins a number of other Prolia® biosimilars already approved or on the market in Korea, including Celltrion’s Stoboclo® and Osenvelt® (approved November 2024, launched by Daewoong in March 2025), Samsung Bioepis/Boryung’s Xbryk® (approved May 2025, launched 1 August 2025), Samsung Bioepis/Hanmi’s Obodence® (launched July 2025), and mAbxience/HK inno.N’s Izambia™ and Denbrayce™ (approved 5 February 2026).