Samsung Bioepis' bone loss biosimilar gains domestic approval

Samsung Bioepis headquarters / Courtesy of Samsung Bioepis

Samsung Bioepis said Sunday its biosimilar treatment for osteoporosis and bone loss has won approval from Korea's Ministry of Food and Drug Safety.

Obodence is a biosimilar for Prolia, the blockbuster osteoporosis drug developed by U.S. biopharmaceutical firm Amgen, commonly used to treat bone loss in patients with prostate cancer or breast cancer. Prolia posted approximately 6.5 trillion won ($4.374 billion) of revenue globally last year, and the Korean market for the drug is valued at 174.9 billion won, according to market tracker IQVIA.

In February, Samsung Bioepis acquired approvals for its Prolia biosimilar in the U.S. and Europe, under the names Ospomyv and Obodence, respectively. With the latest approval, the company can expand treatment options for patients with bone diseases in Korea, Samsung Bioepis said.

"With the approval of Obodence, we have expanded opportunities to treat local bone disease patients at reasonable costs,” said Jung Byoung-in, head of Samsung Bioepis' regulatory affairs.

“And we will continue to strive to create social value, such as improving patient benefits and reducing health insurance costs through biosimilars.”

Following the approval, Samsung Bioepis now has a total of 10 biosimilar products in its portfolio in Korea, including treatments for autoimmune conditions, oncology, ophthalmology, rare blood disorders and kidney disease.

The company signed a domestic sales agreement for Obodence with Hanmi Pharmaceutical last month. Under the agreement, the two companies will cooperate in domestic marketing and distribution for the treatment.