HONG KONG – South Korea’s Daewon Pharmaceutical Co. Ltd. has launched Terrosa, a teriparatide biosimilar for the treatment of osteoporosis, acquired from Hungarian firm Richter-Helm Biotec GmbH & Co KG. It’s the first biosimilar launch for the company.

“This is the first teriparatide component biosimilar in the country, and it is meaningful that it is Daewon’s first biosimilar launch,” said a company official. “Terrosa has proven its effectiveness and safety, with a competitive price sure to be welcomed by patients.”

Daewon said the local osteoporosis market consists of 1 million patients and is worth around ₩200 billion (US$163 million). The market for the injections used in osteoporosis treatment is worth an additional ₩70 billion.

Terrosa is a parathyroid hormone (PTH) gene combination drug treating osteoporosis in postmenopausal women and in men and women at high risk of fractures. The drug was developed by Richter-Helm Biologics, a Helm and Gedeon Richter joint venture. The drug references Forteo by Eli Lilly and Co. and is approved for the same indications in adults. Forteo generated $1.6 billion in global product sales in 2019. The drug substance was manufactured by Richter-Helm Biologics in Germany and the finished product manufactured in Hungary by Gedeon Richter. Terrosa has passed phase I and phase III trials in both Europe and Japan.

Terrosa’s active substance, teriparatide, activates bone formation by stimulating osteoblasts, or bone-forming cells. The substance also increases intestinal absorption of calcium and increases the kidneys’ tubular re-absorption of calcium and excretion of phosphate. Patients take the drug once a day, injecting it via a reusable Terrosa pen.

Daewon acquired the license for the drug in February 2017 from Richter-Helm Biotec, a second joint venture between Helm and Gedeon Richter. The joint venture received marketing approval from the European Commission (EC) in January 2017, and Richter-Helm affiliate Gedeon Richter plc, based in Budapest, launched Terrosa in Europe in late August 2019.

Terrosa was also Richter-Helm Biotec’s first biosimilar launch. Gabor Orban, Richter’s CEO, said that biosimilars “will increase choice and access for patients in the European countries, while providing potential cost savings to health care systems. We look forward to bringing more high quality and affordable biosimilar products to the market."

Almost two years later in July 2019, Daewon received approval from the Korea Ministry of Food and Drug Safety (MFDS) to market the drug. A Gedeon Richter source told BioWorld that a “long-standing relationship with Helm AG” was the reason Daewon was chosen to distribute Terrosa in Korea. Daewon did not reply to BioWorld’s queries as of press time.

Richter-Helm Biotec is planning “further launches … [for Terrosa] in 2020 and the subsequent years,” according to the Gedeon-Richter source. Although further details were not provided, the COVID-19 pandemic “hasn’t had a significant effect on the planned launches,” according to the source. Terrosa is already under registration by Richter-Helm license partners in several countries outside Europe and has been launched in many European countries as well as Japan.

While there are no further products in the Richter-Helm system, the company source pointed to other biosimilars in Gedeon Richter’s pipeline. For example, denosumab, another biosimilar for osteoporosis and oncology indications, is currently in the preclinical stage.  

In late April, Gedeon Richter signed an asset purchase agreement with Taiwanese biologics giant Mycenax Biotech Inc. for tocilizumab, a biosimilar to treat rheumatoid arthritis. Gedeon Richter forked over a down payment of $2 million, with an additional $3 million as an up-front payment upon signature. The agreement gives Gedeon Richter worldwide rights to develop, manufacture and market the drug. Tocilizumab is currently in clinical-stage development.

Meanwhile, Richter-Helm Biologics signed an agreement with U.S.-listed Inovio Pharmaceuticals Inc. on April 30 to expand its manufacturing partnership. That will support large-scale manufacturing of Inovio’s potential COVID-19 vaccine, INO-4800, which is currently in phase I testing in the U.S. and looking to start phase II/III trials in the summer.

Founded in 1958 and based in Seoul, Daewon is best known for its Pelubi tablet, a nonsteroidal anti-inflammatory drug to treat osteoarthritis and back pain. Its Trigel suspension for gastritis is also well-established and widely advertised throughout the country.

Daewon signed a licensing agreement with Korean bioventure Tium Bio Co. Ltd. in February 2019 to grow its biopharmaceutical business. The two companies agreed to develop and commercialize TU-2670, a drug candidate treating endometriosis and uterine leiomyoma.

Daewon stocks gained 0.94% to close at ₩16,150 (US$13.086) on May 18. They rose 0.93% to close at ₩16,300 a day later.

Meanwhile, Gedeon Richter stock, listed in Berlin, was up 2.09% at €19.50 (US$21.17) on May 19, after closing at €19.10 a day earlier.

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