Biosimilars to Prolia compete for the market worth KRW 170B

Competitions among the three big pharmas, Chong Kun Dang-Daewoong-Hanmi, anticipated

Biosimilars have been introduced to the market after the patent expiration of Prolia in March

Amgen stresses the original drug benefits, such as price competitiveness, long-term benefits, and safety

As biosimilars have been introduced following the patent expiration of the osteoporosis treatment, 'Prolia (denosumab),' competition in the market is expected to heat up.

 

As biosimilars from Celltrion and Samsung Bioepis, distributed by Daewoong and Hanmi, respectively, become distributed, the original drug producer, Chong Kun Dang, and the biosimilar companies are expected to engage in active marketing activities.

 

Product photo of Prolia

Amgen’s original drug, Prolia, generates exceptional sales in the domestic osteoporosis treatment market.

 

Last year, Prolia's reimbursement criteria were expanded.

 

Reimbursement has been expanded allowing even borderline patients who reached the treatment target defined by the T‑score for osteoporosis, thereby extending its influence.

 

After surpassing KRW 100 billion in sales with KRW 115.7 billion in 2022, Prolia's sales continued to grow, reaching KRW 151.1 billion in 2023 and KRW 174.9 billion in 2024.

 

However, following the expiration of domestic patents last March, biosimilars have been introduced, inevitably impacting Prolia's sales.

 

The first to enter the market was Celltrion's Stoboclo, which captured the 'first mover' position by receiving marketing approval from the MFDS in November last year—the first biosimilar to denosumab to be approved.

 

4-year Sales Trend for Prolia (unit: KRW 100 million, source: IQVIA)

Stoboclo, which was launched last month on the 19th, features an improved syringe design compared to the original drug, enhancing convenience and safety for healthcare providers.

 

The syringe is designed so that the needle is automatically concealed after injection, allowing for single-handed handling, and minimizing needle-related injury risks.

 

Subsequently, on the 4th, Samsung Bioepis' Prolia biosimilar, Obodence, received domestic marketing approval.

 

Although the reimbursement price for Obodence has not yet been set, it is expected to be launched on the market by the end of this year after completing the reimbursement listing process with the Ministry of Health and Welfare (MOHW).

 

Stoboclo, already available in the market, is expected to capture market share based on the price competitiveness of biosimilars.

 

As of April 1, Prolia's reimbursement price was adjusted from KRW 154,700 to KRW 123,760.

 

In contrast, Stoboclo's reimbursement price is KRW 111,384, approximately KRW 10,000 lower than the original product's price.

 

Although Samsung Bioepis' pricing strategy is difficult to predict, several opinions suggest it will be set at the same level as Stoboclo.

 

However, unlike overseas markets, where biosimilars have strong price competitiveness, the domestic market relies more on sales capabilities, which is likely to drive market competition.

 

We must wait and see, but according to the Health Insurance Review and Assessment Service (HIRA) announcement, by March 18, 2026, the price difference between the original drug, Prolia, and its biosimilar, Stoboclo, will be eliminated.

 

In other words, this implies that the price competitiveness of biosimilars will be lost.

 

Currently, the market is dominated by major domestic pharmaceutical companies with strong sales capabilities, such as Amgen-Chong Kun Dang, Celltrion-Daewoong, Samsung Bioepis-Hanmi Pharmaceuticals.

 

It is anticipated that competition among biosimilars will be influenced by whether they pass the Drug Committee (DC) reviews at hospitals.

 

Based on other biosimilar cases, hospitals tend not to secure two biosimilars, so the extent of a company's network of prescribing hospitals could determine its success.

 

From this perspective, it appears that Stoboclo, which was the first to enter the market, may initially have a competitive edge; however, given that osteoporosis treatments are prescribed not only in university hospitals but also in primary clinics, it remains to be seen what strategies each company will deploy.

 

In Amgen's case, its original product, containing the active ingredient denosumab, is expected to solidify its market position by emphasizing its authenticity and strengthening its partnership with Chong Kun Dang.

 

According to pharmaceutical industry sources, Amgen is actively working to expand its partnership with Chong Kun Dang, especially in university hospitals, to further reinforce its sales capabilities.

 

Prolia's long-term efficacy and safety data, accumulated over many years, may also serve as a strong competitive advantage.

 

Prolia's long-term benefits were demonstrated in two studies, FREEDOM (from August 1, 2004, to June 17, 2008) and FREEDOM Extension (from August 7, 2007, to July 19, 2015).