Daewon Pharmaceutical has launched Terrosa, a teriparatide biosimilar, on the Republic of Korea market, after signing a domestic sales agreement with Richter-Helm Biotec. The drug is intended for the treatment of osteoporosis.
Daewon Pharmaceutical has launched Terrosa, a biosimilar teriparatide for osteoporosis referencing Eli Lilly’s Forsteo, on the Republic of Korea market, according to industry reports.
The launch comes after Daewon, which is based in Seoul, signed a domestic sales contract with Richter-Helm Biotec, which is a joint venture between Helm in Germany and Gedeon Richter in Hungary.
“[Terrosa] has not only proved its effectiveness and safety but also has excellent price competitiveness, which will likely reduce the burden on patients,” the company told the Korea Biomedical Review.
Terrosa is a parathyroid hormone gene recombination drug and is used in men and postmenopausal women with osteoporosis as well as in women with a high risk of fractures. It functions by promoting the action of osteoblasts used in bone formation and is effective in treating osteoporosis fractures and reducing the risk of fractures.
Phase 1 and phase 3 clinical trials conducted in the European Union and Japan have shown Terrosa to aid in the formation of bone in the spine, femur, and hip joints, as well.
Although Terrosa is a bone accelerator and not a bone resorption inhibitor, it is more effective at increasing bone mass compared with existing bone resorption inhibitors. A 4-year postmarketing surveillance study will be conducted due to the drug being listed as an equivalent biologic treatment to the reference product.
According to Daewon, the Republic of Korea osteoporosis treatment market has 1 million patients and is estimated at $162.5 million in size. The injection market for osteoporosis treatment is estimated at $56 million.
The launch became a possibility after 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 2019.
Terrosa was approved by the European Medicines Agency in 2017 and launched in that market in August 2019. It was also launched on the US market in 2019, but not as a biosimilar. In both Europe and the United States, the product was launched as Terrosa.
In the United States in October, 2019, the FDA approved a teriparatide follow-on product to Forsteo. The company, Pfenex, submitted a 505(b)(2) application for approval rather than an abbreviated Biologics License Application.