Samjin joins Faslodex generic race

Dongkook and Samjin secure reimbursement listing…intensifies generic competition

Market remains below KRW 10 billion… expansion as important as market share

Samjin aims to compete with lower price and a broader breast cancer portfolio

Samjin Pharmaceutical has entered the competition for generic versions of AstraZeneca's breast cancer therapy Faslodex (fulvestrant), raising attention on whether this may expand the overall market for fulvestrant products in Korea.

(from the left) Faslodex, Fulvet, Fulveserd

According to the Health Insurance Review and Assessment Service (HIRA), Dongkook Pharmaceutical's Fulverant Prefilled Inj (0.5 g/pack) and Samjin Pharmaceutical's Fulveserd Inj (0.5 g/pack) have been listed for reimbursment, effective as of July 1.

Fulvestrant is a selective estrogen receptor degrader (SERD) that works by degrading and eliminating estrogen receptors, allowing it to remain effective even in patients who have developed resistance to hormone therapy.

The drug is indicated for patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer, a population that accounts for approximately 70% of breast cancer cases in Korea.

The Korean fulvestrant market first opened to generic competition in 2022, when Boryung's Fulvet became the first reimbursed generic following the original drug Faslodex. In February 2025, Korus Korea’s Elbracan was subsequently added to the reimbursement list.

While Samjin officially entered the market following reimbursement approval, Dongkook Pharmaceutical has not announced a commercial launch schedule yet.

However, market conditions remain challenging. Faslodex recorded approximately KRW 3.3 billion in import value in 2024. This is half the level seen after 2023. Boryung's Fulvet  imports recorded only KRW 500 million during the same period.

According to IQVIA, Faslodex generated KRW 6.1 billion in sales last year, while Fulvet recorded approximately KRW 800 million. Korus Korea’s Elbracan has yet to generate meaningful sales.

Although the market has grown in 2025 compared with 2024, the entire fulvestrant segment still remains below KRW 10 billion.

In such a context, later entrants are expected to focus not only on gaining market share from competitors but also on expanding the overall size of the market.

Since receiving reimbursement in 2019, the original Faslodex has undergone a series of reimbursement price cuts following the entry of generic competitors and the expiration of applicable pricing premiums. After signing a Flexible Pricing Agreement with the National Health Insurance Service (NHIS) in June, Faslodex's current listed price stands at KRW 974,917.

The reimbursement price for the earlier generics, Fulvet and Elbracan, is KRW 288,194. By comparison, Samjin's Fulveserd received a lower reimbursement price of KRW 244,965, while Dongkook chose the same reimbursement price as the existing generics.

NHIS results

Accordingly, Samjin is expected to compete by leveraging its relatively lower reimbursement price.

Boryung, however, emphasized that Fulvet should be viewed in the context of sales synergies with the company’s broader oncology portfolio rather than as a standalone product.

A Boryung representative said, "As a leading domestic oncology company, we developed and supply the first fulvestrant generic to provide patients with a broader range of treatment options. We also expect meaningful synergies with our existing breast cancer portfolio."

As Samjin Pharmaceutical is also developing a generic version of Ibrance (palbociclib), it put forward the diversification of its breast cancer portfolio and the improvement of patient access as key strategic priorities.

A Samjin representative said, “Like Petra (letrozole), which we already commercialized, we expect Fulveserd to also establish itself successfully in Korea’s market. We also plan to sequentially introduce additional breast cancer generics, including palbociclib, as well as innovative therapies in Korea."

The representative added, "By maximizing our capability to manufacture active pharmaceutical ingredients in-house, Samjin aims to become a reliable partner capable of providing healthcare professionals and patients with a broad range of treatment options at more affordable prices through a stable supply chain."