Remsima-Onbevzi compete for No.1 rank in the biosimilar mkt

Q3 sales of Remsima surpassed that of Onbevzi…regaining the leading position

Samsung Bioepis' Onbevzi tops KRW 10 billion in ten consecutive quarters…now a stable cash cow

Boryung·Daewoong·Samil·Hanmi began biosimilar sales…initiating sales and marketing

Celltrion's Remsima and Samsung Bioepis' Onbevzi are fiercely competing for the top spot in the Korean biosimilar market.

 

Remsima has now surpassed Onbevzi's sales after nine quarters, following its previous lead in Q4 of last year.

 

Both Remsima and Onbevzi generate quarterly revenues exceeding KRW 10 billion, proving the commercial viability of domestically developed biosimilars.

 

The entry of traditional pharmaceutical companies into the sales of these biosimilars is attributed to the stable market growth.

 

According to the Financial Supervisory Service on November 17, Celltrion's Remsima recorded sales of KRW 12.5 billion in the third quarter, up 11.5% year on year.

 

Remsima surpassed Onbevzi's sales of KRW 10.5 billion by KRW 2 billion, marking the highest domestic revenue among domestically developed biosimilars.

 

This record is based on sales figures disclosed by Celltrion Pharm and Boryung, the companies selling biosimilars from Celltrion and Samsung Bioepis, respectively.

 

Quarterly sales of major domestically-developed biosimilars.

 

ORANGE-Remsima, BLUE-Onbevzi, GREEN-Herzuma (unit: KRW 1 million, source: Financial Supervisory Service)

Remsima is a biosimilar of Remicade, the treatment for autoimmune diseases.

 

It was approved in 2012 as the first domestically developed antibody biosimilar and is used to treat Crohn's disease, ankylosing spondylitis, ulcerative colitis, and rheumatoid arthritis.

 

Onbevzi is a biosimilar of the anti-cancer drug Avastin.

 

It is used 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.

 

This is the first time in three quarters, since Q4 of last year, that Remsima has surpassed Onbevzi's sales.

 

Remsima led Onbevzi by KRW 1.6 billion in Q4 of last year, with KRW 12.1 billion in sales.

 

However, Onbevzi took the lead in Q1 of this year with KRW 10.9 billion, surpassing Remsima by KRW 1.7 billion.

 

Q2 sales of Onbevzi exceeded those of Remsima by KRW 700 million.

 

Remsima had maintained the sales lead among domestically developed biosimilars for 10 years after its launch.

 

Onbevz first surpassed Remsima in Q1 2023 with KRW 9.2 billion in sales, leading by KRW 1 billion.

 

Remsima retook the lead in Q2 2023 with KRW 13.4 billion, surpassing Onbevz by KRW 3.3 billion, but then conceded the lead to Onbevz from Q3 2023 to Q3 of last year, with sales between KRW 8 billion and KRW 9 billion.

 

Since then, Remsima and Onbevz have repeatedly traded the lead.

 

Sales have reversed a total of five times between Remsima and Onbevz over the past three years since 2023.

 

Onbevzi became a stable cash cow, recording sales of over KRW 10 billion for 10 consecutive quarters since first crossing the KRW 10 billion mark in Q2 2023.

 

However, Onbevzi's growth has slowed slightly since recording KRW 11.7 billion in sales in Q2 of last year.

 

After declining to KRW 11.5 billion in Q3 and KRW 10.6 billion in Q4 of last year, it rebounded to KRW 10.9 billion in Q1 of this year, but its sales in Q2 and Q3 slightly decreased from the previous quarter.

 

In the Avastin market, Samsung Bioepis launched Onbevzi in September 2021, followed by Celltrion and Alvogen Korea.

 

Onbevzi, the first biosimilar to enter the market, was equipped with a customized sales force, thereby maximizing its synergy.

 

Samsung Bioepis signed an exclusive domestic sales agreement with Boryung immediately after Onbevzi's approval in South Korea.

 

Boryung is a domestic company with strengths in oncology.

 

Onbevzi's cumulative sales for the first three quarters were KRW 31.7 billion, a 8.4% year-on-year decrease, but it still led Remsima's sales of KRW 31.3 billion by KRW 400 million.

 

Remsima's cumulative sales for the first three quarters decreased by 1.5% from the previous year.

 

Celltrion's Herzuma, a biosimilar of the anti-cancer drug Herceptin, followed Onbevz and Remsima, recording KRW 4.3 billion in Q3 sales, a 21.0% decrease year-on-year.

 

Herzuma's cumulative sales for the first three quarters totaled KRW 15.7 billion, a 1.6% year-on-year decrease.

 

Recently, traditional pharmaceutical companies have entered the biosimilar market.

 

Domestic biotech companies have successfully commercialized 26 biosimilar products across 15 markets.

 

Domestic companies began actively entering the biosimilar market when Celltrion received approval for Remsima in 2012.

 

Celltrion has received MFDS approval for biosimilars targeting Herceptin, MabThera, Humira, Avastin, Eylea, Stelara, Xolair, Prolia, Xgeva, and Actemra.

 

Samsung Bioepis received approval for Etoloce, its first biosimilar product, in 2015.

 

The original drug for Etoloce is Enbrel.

 

Samsung Bioepis has successfully commercialized biosimilars targeting Remicade, Humira, Herceptin, Avastin, Lucentis, Soliris, Eylea, Stelara, Prolia, and Xgeva.

 

LG Chem received approval for Eucept, an Enbrel biosimilar, in 2018 and a Humira biosimilar in 2023.

 

Chong Kun Dang launched biosimilars in the Nesp and Lucentis markets.

 

Samsung Bioepis initially launched the Enbrel biosimilar Etoloce in 2015 and the Remicade biosimilar Remaloce in 2016 through MSD Korea, but transferred the domestic rights for both products to Yuhan in 2017.

 

Yuhan also secured the rights for Samsung Bioepis' Humira biosimilar, Adaloce, in 2021.

 

However, since March of last year, Samsung Bioepis newly established its own sales organization and began direct sales of three autoimmune disease treatments.

 

Samsung Bioepis selected Daewoong Pharmaceutical as its sales partner for Samfenet in 2017, but replaced the partnering company with Boryung in 2021.

 

In 2021, it signed an exclusive domestic sales agreement with Boryung immediately after the domestic approval of the Avastin biosimilar, Onbevzi.

 

Samsung Bioepis chose Samil Pharm as its sales partner for the ophthalmology treatments Lucentis and Eylea biosimilars.

 

Samsung Bioepis selected Hanmi Pharmaceutical as its sales partner for the Prolia biosimilar, Obodence.

 

Prolia, developed by Amgen, works by inhibiting bone resorption and increasing bone density by suppressing osteoclast activity (cells that break down bone).

 

It prevents bone loss and reduces fracture risk in postmenopausal women, suppresses bone metastasis, and protects bone structure, reducing complications in cancer patients.

 

Samsung Bioepis, as the developer of the Prolia biosimilar, is responsible for product production and supply, while both companies jointly handle marketing and sales activities.

 

Daewoong Pharmaceutical entered a co-promotion and distribution agreement with Celltrion Pharm and began domestic sales of Celltrion's Prolia biosimilar, Stoboclo.

 

Daewoong Pharmaceutical jointly sells Stoboclo with Celltrion Pharm in general hospitals and clinics nationwide.

 

Celltrion previously sold its biosimilars in the domestic market through its affiliate, Celltrion Pharm.

 

Stoboclo is the first Celltrion biosimilar sold by a pharmaceutical company other than Celltrion Pharm.

 

Daewoong Pharmaceutical also joined LG Chem's sales effort for its Humira biosimilar, Xelenka.