With a denosumab biosimilar expected to enter the clinical trial site in Korea in earnest, changes in the treatment market are expected.

# According to industry sources on the 24th, the Ministry of Health and Welfare recently announced a preliminary administrative notice of the revision of the 'Detailed Standards and Methods for the Application of Medical Benefits' centered on the listing of the denosumab biosimilar.

Unless there is a major disagreement, the revision is likely to take effect next month.

The item that will be listed is the Celltrion biosimilar ‘Stoboclo prefilled syringe (hereinafter referred to as Stoboclo).’

The drug is a biosimilar version of Amgen’s Prolia that has achieved unrivaled sales in the domestic osteoporosis treatment market, and the drug is expected to compete with the original product starting next month.

The Ministry of Health and Welfare plans to revise the notice to apply the same reimbursement standards as Prolia.

With the notice, interest is shifting to how Stoboclo’s reimbursment listing will spark competition with the original Prolia.

The industry is interested in whether Stoboclo will be able to exert its influence as a biosimilar in the domestic market, as it has in the global market.

Currently, the price of Prolia is KRW 154,700 per 60 mg. Stoboclo’s price is expected to be lower than this because it is a biosimilar.

For reference, the Ministry of Health and Welfare expanded the reimbursement standard for osteoporosis treatment last year. It made it possible to continue applying the reimbursement to patients who have reached the treatment goal of the T-score, which is the standard for osteoporosis treatment and covered those on the borderline.

When measuring bone density using dual-energy X-ray absorptiometry (DXA), the T-score is -2.5 or less (T-score ≤ -2.5), and the patient is approved for reimbursement, the patient is approved for reimbursement for an additional year even if the T-score improves to -2.5 or more and -2.0 or less during treatment.

If the T-score is above -2.5 and below -2.0 even after treatment, the drug will be granted reimbursement for an additional year.

The HIRA has been conducting selective intensive reviews since last year in anticipation of an increase in claims due to the expansion of reimbursement. The biosimilar Stoboclo will also be subject to these reimbursement standards, as will Prolia.

The Ministry of Health and Welfare explained, “As Stoboclo is scheduled to be newly listed, it will be applied reimbursement standards in the same way as existing denosumab injection’s standard, and ‘etc.’ has been added to the product name in the notification category.”

A professor of rheumatology at a tertiary hospital in Seoul said, “Previous osteoporosis drugs had to be taken on an empty stomach in the early morning and required sitting for a long time due to concerns about esophagitis.” He said, “The dosing method was that difficult to take.”

He went on to say, “The treatment paradigm has changed significantly after the introduction of Prolia from the patient's perspective, as it provides injections like vaccinations. This has rapidly restructured the osteoporosis treatment market restructuring,” and expanded the market to expand further.