Remsima KRW 12B·Onbevzi KRW 8.7B…biosimilar competition

Celltrion's Remsima sales have led the Korean biosimilar market for four consecutive quarters

Onbevzi is ranked second after losing the top sales position in the third quarter of last year…dropped 26% compared to two years ago

Celltrion's Remsima and Samsung Bioepis' Onbevzi are in close competition for the top rank in the South Korean biosimilar market. After returning to the No. 1 sales position in the third quarter of last year, Remsima sales have led for four consecutive quarters. Meanwhile, quarterly Onbevzi sales have approached KRW 10 billion, narrowing the sales gap with Remsima.

According to the Financial Supervisory Service (FSS) on the 22nd, domestic sales of Celltrion's Remsima increased 25.0% year-over-year (YoY) in the second quarter to KRW 12.0 billion, leading overall biosimilar sales. After Remsima sales exceeded those of Onbevzi by KRW 2.0 billion, with KRW 12.5 billion in sales, in the third quarter of last year, the product has held the top sales position for four consecutive quarters. Samsung Bioepis' Onbevzi recorded second-quarter sales of KRW 8.7 billion, down 16.0% YoY resulting in a KRW 3.4 billion gap with Remsima.

AI-generated image. Sales trend analysis of Remsima and Onbevzi by year (unit: KRW 1 million; source: FSS). ORANGE: Remsima, BLUE: Onbevzi

The figures were compiled based on sales disclosures by Celltrion Pharm and Boryung, which distribute Celltrion's and Samsung Bioepis' biosimilar products, respectively.

Remsima is a biosimilar referencing the autoimmune disease therapeutic Remicade. In 2012, it was approved as South Korea's first domestically developed antibody biosimilar. Remsima is indicated for the treatment of conditions including Crohn's disease, ankylosing spondylitis, ulcerative colitis, and rheumatoid arthritis.

Onbevzi is a biosimilar referencing the oncology therapeutic Avastin. It is an anticancer agent indicated for 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.

Although the Korean biosimilar market was previously led by its first commercial drug, Remsima, Onbevzi sales expanded rapidly after its entry, establishing a race between two leading pharmaceuticals.

Remsima remained the top-selling domestically developed biosimilar for a decade following its commercial launch. In the first quarter of 2023, Onbevzi's quarterly sales surpassed Remsima's for the first time, reaching KRW 9.2 billion and leading by KRW 1.0 billion. While Remsima's sales returned to the lead in the second quarter of 2023 at KRW 13.4 billion, exceeding Onbevzi by KRW 3.3 billion, Onbevzi's sales held the top ranking from the third quarter of 2023 through the third quarter of 2024. Although Remsima sales reclaimed the top position in the fourth quarter of 2024, Onbevzi sales led again in the first and second quarters of last year.

Remsima sales exceeded Onbevzi's by KRW 2.0 billion, with KRW 12.5 billion in sales in the third quarter of last year, maintaining the lead for four consecutive quarters through the second quarter of this year. While Remsima's sales margin surpassed Onbevzi by KRW 5.9 billion in the fourth quarter of last year, the gap narrowed to KRW 4.2 billion in the first quarter and KRW 3.4 billion in the second quarter of this year, respectively.

In the Avastin market, Samsung Bioepis launched Onbevzi in September 2021, followed by subsequent market entries from Celltrion and Alvogen Korea. Market analysis suggests that Onbevzi maximized commercial synergies through its first-pharma entry into the biosimilar market and its specialized commercial capabilities. Immediately following domestic regulatory approval for Onbevzi, Samsung Bioepis signed an exclusive domestic distribution agreement with Boryung. Boryung is recognized as one of Korea's leading pharmaceutical companies, with established commercial strength in oncology.

After surpassing KRW 10.0 billion in quarterly sales for the first time in the second quarter of 2023, sales of Onbevzi exceeded KRW 10.0 billion for consecutive quarters. However, they dropped below KRW 10.0 billion starting in the fourth quarter of last year. Sales in the second quarter of this year decreased by 26.2% compared to two years prior.

In recent years, traditional pharmaceutical companies have increasingly entered the biosimilar market. Domestic biopharmaceutical developers have successfully commercialized 26 biosimilar products across 15 therapeutic markets.

Following Celltrion's regulatory approval for Remsima in 2012, domestic biopharmaceutical companies aggressively targeted the biosimilar market. Celltrion has secured marketing authorizations from the Ministry of Food and Drug Safety (MFDS) for biosimilars referencing Herceptin, MabThera, Humira, Avastin, Eylea, Stelara, Xolair, Prolia, Xgeva, and Actemra.

Samsung Bioepis received its first biosimilar approval in 2015 with Etoloce, referencing the originator biologic Enbrel. Samsung Bioepis has successfully commercialized biosimilar products across multiple therapeutic spaces, including Remicade, Humira, Herceptin, Avastin, Lucentis, Soliris, Eylea, Stelara, Prolia, and Xgeva.

LG Chem obtained approval for its Enbrel biosimilar Eucept in 2018 and secured authorization for a Humira biosimilar in 2023. Chong Kun Dang has introduced biosimilars targeting the Nesp and Lucentis markets.

Initially, Samsung Bioepis commercialized its Enbrel biosimilar Etoloce and Remicade biosimilar Remaloce via MSD Korea in 2015 and 2016, respectively, before transferring domestic commercial rights for both products to Yuhan Corp in 2017. Yuhan also acquired the rights to Adalloce, Samsung Bioepis' Humira biosimilar, in 2021. However, since March of last year, Samsung Bioepis has established its own internal sales division and transitioned to direct commercialization of these three autoimmune disease therapeutics.

In 2017, Samsung Bioepis designated Daewoong Pharmaceutical as its commercial partner for Samfenet, but transferred its distribution partnership to Boryung in 2021. After domestic approval of its Avastin biosimilar Onbevzi in 2021, Samsung Bioepis signed an exclusive domestic marketing agreement with Boryung. Samsung Bioepis also selected Samil Pharmaceutical as its distribution partner for its ophthalmic biosimilars referencing Lucentis and Eylea.

Samsung Bioepis selected Hanmi Pharm as its commercialization partner for its Prolia biosimilar, Obodence. Developed by Amgen, Prolia inhibits osteoclast activity to prevent bone resorption and increase bone mineral density. The drug prevents bone loss and lowers fracture risk in postmenopausal women, while also reducing complications in cancer patients by suppressing bone metastases and preserving skeletal integrity. As the developer of the Prolia biosimilar, Samsung Bioepis oversees manufacturing and supply, while both companies jointly manage marketing and sales in South Korea.

Daewoong Pharmaceutical entered into a co-promotion and distribution agreement with Celltrion Pharm to launch domestic sales of Celltrion's Prolia biosimilar, Stoboclo. Daewoong Pharmaceutical will co-promote Stoboclo nationwide across general hospitals and outpatient clinics alongside Celltrion Pharm. Previously, Celltrion sold its biosimilars in the domestic market exclusively through its subsidiary Celltrion Pharm. Stoboclo sales mark the first time a pharmaceutical company other than Celltrion Pharm distributes a Celltrion biosimilar. Daewoong Pharmaceutical has also joined the commercialization of LG Chem's Humira biosimilar, Xelenka.