Daewon Pharmaceutical said it has won the Ministry of Food and Drug Safety’s approval to market Terrosa, an osteoporosis biosimilar (Original: Forsteo) developed by Richter-Helm Biotec.
|Richter-Helm Biotec's osteoporosis treatment Terrosa|
Terrosa is a recombinant drug that uses parathyroid hormone (PTH) and treats osteoporosis in postmenopausal women as well as men and women at high risk of fracture by promoting the work of osteoblasts in the bone to promote bone formation.
The drug uses a self-administering pen that requires one injection a day, and patients can replace the cartridge on the pen for continued use.
Daewon signed a sales contract with Richter-Helm Biotec in February 2017 and has been preparing to release the drug. The launch of the biosimilar became possible as the patent for "stable teriparatide solution"' expired in December 2018, and the patent for "increasing bone toughness and rigidity and fracture reduction method" expired in August this year.
Existing osteoporosis treatments, mainly composed of bisphosphonate that inhibits bone resorption, was effective in increasing bone density but ineffective in restoring bone microstructure.
Terrosa, however, is not a bone resorption inhibitor, but a bone formation promoter.
The company has also obtained a four-year post-marketing surveillance period as the ministry listed the drug as an equivalent biologic after the company confirmed the non-inferiority of the biosimilar.
"With the increasing proportion of PTH (parathyroid hormone) drugs in the global market, the company expects that the drug will have a highly competitive value in Korea as the nation's first biosimilar licensed with teriparatide as the main ingredient," Daewon CEO Choi Tae-hong said.
As Terrosa is Daewon's first biopharmaceutical brand, the sales approval is meaningful as it means that the company has taken its first step into the bio-market, Choi added.