3 new K-biosimilar approvals last year…second-highest

Newly approved 2 products by Samsung Bioepis·1 product by Sam Chung Dang Pharm last year

Record high approvals in 2024, with 9 products…3 approvals in 2015 and 2022

11 products each from Celltrion and Samsung Bioepis…biosimilar approvals speed off

Last year, South Korean biopharmaceutical companies received approval of three new biosimilar products. It was the second-highest annual output following the record-breaking eight approvals in 2024. Samsung Bioepis and Celltrion have seen their follow-up pipelines reach the commercialization stage one after another, while Sam Chun Dang Pharm successfully entered the market with its first biosimilar, expanding the number of domestic biosimilar players to five. Currently, Celltrion and Samsung Bioepis received 11 approved biosimilars each.

According to industry sources on the 5th, domestic firms obtained approval from the Ministry of Food and Drug Safety (MFDS) for four new biosimilar products last year. Samsung Bioepis secured two of these approvals, while Sam Chun Dang Pharm obtained one.

 Samsung Bioepis received approval for Obodence (a biosimilar to Prolia) in April 2025, followed by Xbryk (a biosimilar to Xgeva) in May. Both Prolia and Xgeva were initially developed by Amgen, using the same active ingredient, denosumab, but with different dosing schedules and administration cycles. Prolia is used for treating osteoporosis, whereas Xbryk is indicated for preventing skeletal-related events in patients with bone metastases and for treating giant cell tumors of bone.

In September 2025, Sam Chun Dang Pharm's Vgenfli, a biosimilar to Eylea (aflibercept), cleared its final regulatory hurdle. This product is indicated for ophthalmic conditions such as wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema. This marks Sam Chun Dang Pharm's first domestic biosimilar approval, entering a competitive field where Samsung Bioepis and Celltrion had already secured approvals for their respective Eylea biosimilars in 2024.

The number of biosimilar approvals received by South Korean pharmaceutical and biotech companies by year (unit: number, source: MFDS)

The three biosimilar approvals in 2025 were the second-highest in record. It recorded 9 in 2024, and the previous high was 3 in 2015 and 2022. 

Beyond new product entries, domestic firms are continuously strengthening their market competitiveness through supplemental formulation approvals.

Celltrion obtained approval for an Auto-Injector (AI) formulation of Omlyclo in December 2025. This followed the June 2024 approval of the pre-filled syringe (PFS) version. Omlyclo is a biosimilar to Xolair (omalizumab), used for chronic idiopathic urticaria and asthma. The AI formulation is a unique option not currently offered by the original manufacturer in Korea, designed to enhance treatment accessibility for patients who find it challenging to visit medical institutions.

Similarly, Celltrion added two new types of Avtozma (an Actemra biosimilar) in February 2025.

Samsung Bioepis received approval for its Eylea biosimilar, Afilivu, in 2024, and introduced a pre-filled syringe version last year.

To date, South Korean biopharmaceutical companies have successfully commercialized 27 products across 15 therapeutic areas.

Celltrion pioneered this space in 2012 with Remsima and has since secured approvals for biosimilars referencing Herceptin, MabThera, Humira, Avastin, Eylea, Stelara, Xolair, Prolia, Xgeva, and Actemra.

Samsung Bioepis began its journey in 2015 with Etoloce (Enbrel biosimilar) and has successfully expanded into areas referencing Remicade, Humira, Herceptin, Avastin, Lucentis, Soliris, Eylea, Stelara, Prolia, and Xgeva.

LG Chem and Chong Kun Dang have also made notable entries into the Enbrel, Humira, Nesp, and Lucentis markets.

Celltrion and Samsung Bioepis received approval for 11 biosimilars each. Celltrion and Samsung Bioepis account for 85% of the 26 approved products. 

Recently, traditional pharmaceutical companies have increasingly joined forces with these biosimilar developers for domestic distribution.

While Samsung Bioepis initially partnered with MSD Korea, it later transferred rights to Yuhan Corp for several autoimmune treatments. However, in March 2024, Samsung Bioepis established its own internal sales organization for direct distribution. It currently maintains partnerships with Boryung for its oncology portfolio (Samfenet and Onbevzi) and Samils Pharmaceutical for its ophthalmology products. For Obodence, Samsung Bioepis selected Hanmi Pharmaceutical as its marketing partner, sharing domestic sales responsibilities.

In 2017, Samsung Bioepis initially selected Daewoong Pharmaceutical as the sales partner for Samfenet but switched the distributor to Boryung in 2021. Immediately following the domestic approval of the Avastin biosimilar Onbevzi in 2021, the company signed an exclusive domestic sales agreement with Boryung. For its ophthalmic disease treatments, Samsung Bioepis chose Samil Pharmaceutical as the sales partner for its Lucentis and Eylea biosimilars.

Samsung Bioepis recently selected Hanmi Pharmaceutical as the sales partner for Obodence. Samsung Bioepis acts as the developer responsible for production and supply, while both companies jointly manage domestic marketing and sales activities.

Daewoong Pharmaceutical entered into a joint sales and distribution agreement with Celltrion Pharm to begin domestic sales of Celltrion's Prolia biosimilar, Stoboclo. Daewoong Pharmaceutical is conducting joint sales of Stoboclo across general hospitals and clinics nationwide alongside Celltrion Pharm. While Celltrion previously sold its biosimilars in the domestic market exclusively through its affiliate, Celltrion Pharm, Stoboclo is the first product from a pharmaceutical company other than Celltrion Pharm to be distributed in the domestic market. Additionally, Daewoong Pharmaceutical has joined LG Chem's sales efforts for its Humira biosimilar, Xelenka.