As South Korea grapples with an aging population, the importance of bone health has come to the forefront. (Image courtesy of Korea Bizwire)
SEOUL, Dec. 18 (Korea Bizwire) – As South Korea grapples with an aging population, the importance of bone health has come to the forefront, prompting local pharmaceutical and biotech companies to intensify their efforts to develop and market generic osteoporosis treatments.
According to industry sources on December 17, the patent for Prolia, an osteoporosis medication developed by the multinational pharmaceutical company Amgen, is set to expire in February 2025 in the United States and November 2025 in Europe. Prolia’s global sales last year reportedly reached approximately 4.6 trillion won.
In response, the biotech industry is accelerating the development and approval of biosimilars for Prolia. Recently, Celltrion applied to the U.S. Food and Drug Administration (FDA) for product approval of ‘CT-P41′, a biosimilar of Prolia and Xgeva. Xgeva, another brand name for Prolia, is approved for preventing bone complications in cancer patients.
Samsung Bioepis also announced in October that its Prolia biosimilar ‘SB16′ had demonstrated equivalence to the original drug in phase 1 and 3 clinical trials.
The incidence of osteoporosis, a condition characterized by decreased bone mass and deterioration of bone microstructure, making bones more prone to fractures, rises sharply after the age of 50, particularly among women.
According to the Health Insurance Review & Assessment Service, there were approximately 1.1 million women and 67,000 men diagnosed with osteoporosis last year, marking increases of about 22 percent and 15 percent, respectively, compared to 2018.
Osteoporosis treatments can be broadly classified into bone resorption inhibitors and bone formation stimulants. Prolia works by binding to a key mediator in bone resorption, RANKL, reducing bone loss.
Other bone resorption inhibitors include female hormone preparations that inhibit calcium release from bones and selective estrogen receptor modulators (SERMs) that improve bone quality. Bone formation stimulants include agents that activate osteoblasts, like parathyroid hormone receptor agonists.
Efforts to sell foreign osteoporosis treatments in South Korea are also increasing. HK inno.N signed a contract in December of last year with the Spanish pharmaceutical company mAbxience to introduce Prolia and Xgeva biosimilars. mAbxience is currently conducting phase 3 clinical trials of these biosimilars, with plans for domestic approval and sales post-clinical trial completion, as stated by HK inno.N.
Dong-A ST is currently marketing Actonel, an osteoporosis treatment from Sanofi, and Teribone from the Japanese pharmaceutical company Asahi Kasei Pharma.
The release of health supplements aimed at improving medication convenience for joint and cartilage health is also on the rise.
Chong Kun Dang Pharma recently launched a Boswellia extract supplement that satisfies various functionalities such as joint and cartilage health, immunity, and antioxidants with just one tablet a day, while JW Pharmaceutical released a chondroitin mucopolysaccharide protein supplement which meets the recommended daily intake with just two tablets a day.
M. H. Lee (mhlee@koreabizwire.com)
