K-biosimilars gain influence in domestic market

Remsima led domestic sales last year… retakes the lead over Onbevzi after one year

Onbevzi posts KRW 40 billion in sales backed by Boryung’s sales force

Daewoong joins competition with a Prolia biosimilar, first-year sales reach KRW 11.8 billion

Domestically developed biosimilars have gradually expanded their influence in the domestic market. Celltrion’s Remsima and Samsung Bioepis’s Onbevezi competed for the top spot by a narrow margin, both recording sales in the KRW 40 billion range. Celltrion’s Prolia biosimilar, joined by Daewoong Pharmaceutical, surpassed KRW 10 billion in sales in its first year of release. This trend reflects the increasing involvement of traditional pharmaceutical companies in biosimilar sales, which has strengthened market penetration.

According to the Financial Supervisory Service on the 7th, Celltrion’s Remsima recorded KRW 45.5 billion in sales last year, up 3.4% year-on-year, securing the top spot among domestically developed biosimilars. In 2024, Samsung Bioepis’s Onbevzi took the lead with KRW 45.2 billion, but last year Remsima overtook it by KRW 5.5 billion. The figures are based on sales disclosed by Celltrion Pharm and Boryung, which handle domestic sales for Celltrion and Samsung Bioepis biosimilars, respectively.

Remsima is a biosimilar of the autoimmune treatment Remicade. It was approved in 2012 as Korea’s first domestically developed antibody biosimilar. It is used to treat Crohn’s disease, ankylosing spondylitis, ulcerative colitis, and rheumatoid arthritis.

Onbevzi is a biosimilar version of the oncology drug Avastin. It is an anticancer drug used to treat metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer.

Being the first biosimilar product introduced to the domestic market, Remsima had long led sales, but the rapid growth of Onbevzi since its introduction shifted the market into a duopoly structure.

In 2023, Remsima maintained a narrow lead of KRW 0.8 billion, but in 2024, Onbevzi overtook it for the first time by KRW 1.2 billion. However, Onbevzi’s sales declined 11.5% year-on-year to KRW 40 billion last year, allowing Remsima to regain the top position.

The domestic biosimilar market is drawing attention as a battleground driven by traditional pharmaceutical companies’ sales capabilities.

In the Avastin market, Samsung Bioepis launched Onbevzi in September 2021, followed by entries from Celltrion and Alvogen Korea. As the first entrant, Onbevzi maximized its advantage by leveraging tailored sales strategies. Samsung Bioepis also secured an exclusive domestic sales agreement with Boryung immediately after approval. Boryung is known for its strong presence in oncology sales.

Celltrion’s biosimilars are marketed domestically through Celltrion Pharm. Celltrion’s Herzuma, a biosimilar version of Herceptin, recorded KRW 21.9 billion in sales last year, up 2.8%, ranking behind Onbevzi and Remsima. Truxima, a biosimilar version of MabThera, recorded KRW 12.3 billion in sales, up 7.9%.

While domestically developed biosimilars are still far from achieving commercial success in the global market, they appear to be gradually expanding their influence with the support of traditional pharmaceutical companies.

Last year, 8 of Celltrion’s 12 biosimilar product lines sold in the global market exceeded KRW 100 billion in sales. Remsima recorded sales of KRW 1.0495 trillion last year, surpassing the KRW 1 trillion mark for the second consecutive year.

Remsima SC generated KRW 717.2 billion in sales, up 27.1% year-on-year. Zymfentra grew from KRW 36.6 billion in 2024 to KRW 122.2 billion last year, more than tripling and surpassing KRW 100 billion. Remsima SC is a subcutaneous formulation developed from the original intravenous Remsima, and it has been approved in the U.S. as a new drug under the name Zymfentra.  Truxima and Herzuma generated sales of KRW 526.3 billion and KRW 217.1 billion, respectively, in the global market last year.

Recently, sales competition has been intensifying with traditional pharmaceutical companies joining the biosimilar market en masse.

Samsung Bioepis has established disease-specific sales capabilities tailored to biosimilars.

It initially partnered with Daewoong Pharmaceutical for its Herceptin biosimilar in 2017 but switched to Boryung in 2021. Immediately after receiving domestic approval for Onbevzi, a biosimilar of Avastin, in 2021, the company signed an exclusive domestic sales agreement with Boryung. Samsung Bioepis selected Samil Pharmaceutical as the sales partner for biosimilars of Lucentis and Eylea, treatments for ophthalmic diseases.

Last year, Samsung Bioepis selected Hanmi Pharmaceutical as its domestic sales partner for its Prolia biosimilar Obodence. Samsung Bioepis handles production and supply, while both companies jointly manage marketing and sales. Its original version, Prolia, which was developed by Amgen, works by inhibiting the activity of osteoclasts that break down bone, thereby preventing bone resorption and increasing bone density. It prevents bone loss in postmenopausal women and reduces the risk of fractures, while in cancer patients, it inhibits bone metastasis and protects bone structure to reduce complications.

Daewoong Pharmaceutical signed a joint sales and distribution agreement with Celltrion Pharm last year and began domestic sales of Celltrion’s Prolia biosimilar, Stoboclo. Daewoong Pharmaceutical is conducting joint sales of Stoboclo with Celltrion Pharm at general hospitals and clinics nationwide. Celltrion has sold biosimilars in the domestic market through its affiliate, Celltrion Pharm. Stoboclo is the first Celltrion biosimilar to be sold by a pharmaceutical company other than Celltrion Pharm. Stoboclo generated sales of KRW 11.8 billion last year.

Daewoong Pharm’s strategy is to expand prescriptions at major general and university hospitals nationwide to grow Stoboclo into a ‘mega blockbuster’ with annual sales exceeding KRW 100 billion. Currently, Stoboclo has been introduced to more than 50 major general and university hospitals nationwide, rapidly expanding its prescription base. Daewoong has also joined the sales efforts for LG Chem’s Humira biosimilar Xelenka.