HONG KONG – Daewon Pharmaceutical Co. Ltd., based in Seoul, South Korea, has received the approval from the country's Ministry of Food and Drug Safety (MFDS) to market Terrosa, a biosimilar teriparatide for osteoporosis treatment developed by Richter-Helm Biotec GmbH & Co. KG, of Hamburg, Germany.

The Korean company will launch the biosimilar on the domestic market in the second quarter of next year.

Terrosa is dosed once daily via a self-administered injection pen, and the cartridges can be replaced for long-term use. The biosimilar references Forteo by Eli Lilly and Co. and is developed to treat osteoporosis in men and postmenopausal women at increased risk of fracture. The original drug is also a treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women. Forteo generated $1.6 billion in global product sales last year.

The European Commission (EC) approved the marketing of Terrosa in January 2017. The original drug's 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. Richter-Helm Biotec's affiliate, Gedeon Richter plc, based in Budapest, Hungary, launched Terrosa in Europe in late August.

Terrosa's active substance, teriparatide, is a recombinant form of human parathyroid hormone (PTH). According to the EMA, teriparatide acts as a hormone to stimulate bone formation by acting on osteoblasts, or bone-forming cells. Teriparatide also increases the absorption of calcium from food and prevents too much calcium being passed out in urine.

The EMA also said lab studies comparing Terrosa with Forteo have shown that the active substance in Terrosa is highly similar to that in Forteo in terms of structure, purity and biological activity. A study in 54 healthy women has proved that the same doses of the two medicines given by injection produced similar levels of teriparatide in the body. Also, Terrosa and Forteo produced similar effects on calcium levels in the blood.

Terrosa will be Daewon's first biosimilar launch.

To grow its biopharmaceutical business, the company signed a licensing agreement in February with Korean bioventure Tium Bio Co. Ltd., based in Seongnam, Gyeonggi-do, to develop and commercialize TU-2670, an endometriosis and uterine leiomyoma drug candidate. Tium has completed phase I testing for the drug, and Daewon plans to launch the product in 2025, assuming success in the remaining clinical studies.

"Licensing TU-02670 and marketing Terrosa are milestones for us to expand our biopharmaceutical field. Terrosa, in particular, will be highly competitive in the Korean market as the country's first biosimilar licensed with teriparatide as a main ingredient," a spokesman at Daewon told BioWorld Asia.

Osteoporosis treatment market in Korea

According to consultant company Iqvia Korea Co. Ltd., the osteoporosis treatment market in Korea reached ?200 billion (US$172.3 million) last year, from ?150 billion in 2015, an annual growth of 10%.

Among various treatments for osteoporosis, bisphosphonate has the largest portion of prescriptions, reaching ?132.2 billion, which accounted for 66% of osteoporosis drugs in 2018. In addition, prescriptions of teriparatide reached ?24.9 billion, selective estrogen receptor modulators (SERM) amounted to ?2.76 billion and denosumab reached ?14.3 billion last year.

In Korea, the biggest player is Forteo, which has increased sales year by year, generating ?13.2 billion in sales in 2016, ?16.3 billion in 2017, and ?21.1 billion in 2018 in Korea.

Another major player is Prolia (denosumab) by U.S. pharmaceutical giant Amgen Inc. Prolia's sales in Korea jumped from ?3.7 billion in 2017 to ?14.3 billion in 2018.

Teribone (teriparatide acetate) by Dong-A ST. Co. Ltd has raised its sales, too. In 2014, Dong-A ST licensed Teribone as a once-a-week administration from Japanese pharmaceutical firm Asahi Kasei Pharma Corp., of Tokyo. Launched in 2016, the drug earned ?700 million in sales in 2016, ?3.1 billion in 2017, and ?3.8 billion in 2018.

Founded in 1958, Daewon is well known for its Pelubi tablet, a nonsteroidal anti-inflammatory drug (NSAID) that is expected to generate annual sales of up to ?24 billion this year. The company's Freefol-MCT Injection, microemulsion Propofol and Trigel Suspension, a gastritis therapy, are also well established in the market.

"By diversifying production, Daewon is expected to earn ?318 billion (+10.9% YoY) of sales and ?34 billion (+10.6% YoY) of operating profit this year," Kyungjun Moon, an analyst at IBK Securities Co. Ltd., told BioWorld Asia.

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