Supplied at a Price 13% Lower Than the Original
Samsung Bioepis and Hanmi Pharmaceutical are launching Obodenes, a treatment for postmenopausal osteoporosis and related conditions, in the domestic market on July 1.
Obodenes is a biosimilar of Prolia, a blockbuster drug developed by Amgen. Prolia recorded approximately $4.374 billion (about 6.5 trillion KRW) in global sales last year, with the domestic market size reaching about 174.9 billion KRW.
Obodenes received product approval from the Ministry of Food and Drug Safety in April. Prior to this, in March, Samsung Bioepis and Hanmi Pharmaceutical signed a marketing partnership agreement. Under this arrangement, Samsung Bioepis is responsible for production and supply, while both companies jointly conduct marketing and sales activities.
The price of Obodenes is set at 108,290 KRW (for 60mg/1ml), which is approximately 13% lower than the original drug, and it has been listed for reimbursement.
The advantages of Obodenes include convenient in-hospital storage and reduced injection pain due to its thin 29G needle. The product is also backed by global Phase 3 clinical trial data involving 457 postmenopausal osteoporosis patients, including Korean participants, across five countries.
Based on these research results and other data, Obodenes has demonstrated clinical equivalence to the original drug. As a result, it received product approval from both the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February.
Lee Sanghyun, Executive Director and Head of Domestic Sales at Samsung Bioepis, stated, "Obodenes, with its reasonable pricing and quality competitiveness recognized by global regulatory authorities, is expected to be a more meaningful alternative for osteoporosis patients in Korea, rather than just a simple substitute for the original drug."
Park Myunghee, Executive Director and Head of Domestic Business Division at Hanmi Pharmaceutical, said, "By introducing Obodenes, Hanmi Pharmaceutical will expand its osteoporosis treatment portfolio and enhance its brand competitiveness as a leading company in osteoporosis treatments. Leveraging our domestic sales and marketing experience with Labondy, a leading oral osteoporosis treatment, Obodenes will provide an evidence-based option for a wide range of osteoporosis patients."
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