Developing and Treating Osteoporosis: The Role of Generic Drugs and Functional Foods

Symptoms of Osteoporosis / Provided by the Korean Bone Metabolism Association

As the importance of bone health increases with an aging population, domestic pharmaceutical and biologics companies are working to develop and sell generic drugs to treat osteoporosis.

According to the pharmaceutical and biological industry, on the 17th, the patent of “Prolia” (ingredient name: denosumab), an osteoporosis treatment developed by multinational pharmaceutical company Amgen, will expire in February and November 2025 in the United States and Europe , respectively.

Last year, Prolia’s global sales were about 4.6 trillion won.

As a result, the biologics industry is accelerating the development and approval of Prolia biosimilars (generic biopharmaceutical drugs).

Recently Celltrion[068270]has applied to the US Food and Drug Administration (FDA) for approval of the product “CT-P41”, a biosimilar of Prolia and Xzyva. XZiva is another product name for Prolia, approved for the treatment and prevention of complications of bone metastases in cancer patients.

Samsung Bioepis also announced in October that it had confirmed the equivalence of “SB16,” a biosimilar of Prolia, to the original drug through phase 1 and 3 clinical trials.

Osteoporosis is a disease in which bones become weak and prone to fractures due to decreased bone mass and abnormal microstructure. It is known to increase rapidly after age 50 and occurs more often in women than men.

According to the Health Insurance Review and Evaluation Service, the number of osteoporosis patients last year was 1,115,060 women and 66,745 men, up about 22% and 15%, respectively, from 2018.

The bones appear to remain unchanged on the outside, but in reality the processes of “resorption”, in which old bone is removed, and “formation”, in which new bone is created, are repeated.

Treatments for osteoporosis are largely divided into inhibitors of bone resorption and promoters of bone formation.

Prolia is a drug that reduces bone resorption by binding to RANKL, an important mediator of osteoclast differentiation and activation.

Additionally, there are bone resorption inhibitors such as female hormones that inhibit the release of calcium from bones and “selective estrogen receptor modulators” that improve bone quality through the action of estrogen. Promoters of bone formation include “parathyroid hormone receptor agonists” which act to activate osteoblasts.

Efforts to sell overseas osteoporosis treatments domestically are also active.

Hong Kong Innoen[195940]signed a contract with the Spanish pharmaceutical company “Map Science” for the introduction of biosimilars Prolia and Xzyva in December last year. Currently, Map Science is conducting a phase 3 clinical trial for the biosimilar, and after completing the clinical trial, plans to apply for approval and sell it by introducing domestic licensing and sales rights, HK InnoN added.

Dong-A ST sells Sanofi’s osteoporosis treatment “Actonel” and “Terrybone” from Japanese pharmaceutical company Asahi Kasei Pharma.

The launch of functional foods for joint and cartilage health that improve the convenience of medications is also active.

Chong Kun Dang[185750]Recently launched “Joint Health Project 365 Boswellia 7 Days”, a boswellia extract ingredient that fulfills various functionalities such as joint and cartilage health, immunity and antioxidants, with just one pill per day. JW Pharmaceutical[001060]has also launched “Joint Health Chondroitin Mucopolysaccharide Protein 1200”, which meets the recommended daily dose by taking 2 tablets per day (Seoul = Yonhap News) [End_mark]

#Osteoporosis #treatment #bones #healthy