Shing Poong Pharm’s Prolia biosimilar approved in Korea

MFDS approves osteoporosis drug licensed from India’s Enzene …7th Prolia biosimilar to enter Korea

Shin Poong Pharm has secured marketing authorization for Denovon, a biosimilar version of Amgen’s blockbuster osteoporosis treatment Prolia (denosumab), bringing the product one step closer to launch. Given the usual timetable for health insurance pricing and listing, Denovon is expected to enter the market around the end of the year.

With 7 Prolia biosimilars now approved in Korea, competition in the market is expected to intensify further.

On the 3rd, the Ministry of Food and Drug Safety approved Shin Poong’s Denovon Prefilled Syringe Injection, a denosumab treatment for osteoporosis.

Denovon is supplied as a 60 mg/1 mL prefilled syringe formulation. Like the reference product Prolia, it is indicated for ▲the treatment of osteoporosis in postmenopausal women, ▲increasing bone mass in men with osteoporosis, ▲glucocorticoid-induced osteoporosis, and ▲bone loss in patients with nonmetastatic prostate cancer or breast cancer. Shin Poong acquired exclusive rights to develop and market the product in Korea from India’s Enzene Biosciences in 2021.

Seven biosimilars vie for market…first 4 biosimilars already secure reimbursement listing

The approval of Denovon brings the total number of Prolia biosimilars authorized in Korea to seven. Shin Poong is the latest company to join a field that already includes Celltrion, Samsung Bioepis, LG Chem, HK inno.N, Daewon Pharmaceutical and Alvogen Korea.

Four of the products have already secured reimbursement and are competing in the market. According to the national health insurance reimbursement list, four 60 mg Prolia biosimilars – Samsung Bioepis’ Obodence, Celltrion’s Stoboclo, HK inno.N’s Izambia and Daewon Pharmaceutical’s Junode – are already listed and are being sold in Korea.

Samsung Bioepis (Xbryk), Celltrion (Osenvelt) and HK inno.N (Denbrace) have also received reimbursement approval for their biosimilar versions of Xgeva 120 mg, which is used to treat skeletal complications in patients with cancer.

Shin Poong’s newly approved Denovon will now undergo the reimbursement process alongside LG Chem’s Jubbonti and Alvogen Korea’s Ducolia, neither of which has yet been listed.

Late entrants seek foothold in KRW 170 billion blockbuster market

Amgen’s Prolia

The Korean Prolia market generates approximately KRW 170 billion in annual prescriptions, making Prolia the largest product in the osteoporosis treatment market. Its convenient once-every-six-month dosing regimen and continued coverage under national health insurance criteria have helped it establish a solid prescription base.

In the existing market, early biosimilar entrants are leveraging approvals from drug committees at hospitals and clinics to carve out market share against the sales force of Chong Kun Dang, which holds the domestic marketing rights to the originator Prolia.

Later entrant Shin Poong recently revised its agreement with originator Enzene to strengthen its competitive position. Ahead of the launch, Shin Poong secured ▲adjusted the supply price, ▲added sublicensing rights, and ▲a technology transfer option to the agreement.

The adjusted supply price is expected to improve both pricing competitiveness and distribution margins. The sublicensing rights also open the door to co-promotion partnerships with pharmaceutical companies that have strong sales networks among local clinics (orthopedics, obstetrics and gynecology, and internal medicine), which account for a large share of prescriptions.

An industry official said, “Four biosimilars have already secured reimbursement and are moving to establish an early lead, so an attractive price and a comprehensive sales network encompassing local clinics will be essential for any later entrant. With Shin Poong gaining greater flexibility by restructuring its agreement, the key question will be what kind of partnership it uses to establish itself in the market after securing reimbursement, which is expected around the end of the year.”