19 K-biosimilar products sold in 11 markets after 12 yrs

12 years after the introduction of the first Korean biosimilar

3 Samsung Bioepis biosimilars were approved in Korea this year

Celltrion’s Remsima was first approved in 2012... Remicade, Stelara approved in 11 regions

Samsung Bioepis owns 9 products, the most amount of licensed biosimilar products…Cetllrion commercialized 6 products

Domestic pharmaceutical and biotech companies have succeeded in commercializing biosimilars in 11 areas.

 

In the 12 years since Celltrion's Remsima was introduced, 19 biosimilars have received domestic approval.

 

Among the companies, Samsung Bioepis has entered 9 markets, the most among Korean companies.

 

According to the Ministry of Food and Drug Safety, Samsung Bioepis received approval for Stelara’s biosimilar Epyztek on November 11.

 

This is the first time Samsung Bioepis has received approval for a Stelara biosimilar in Korea.

 

Stelara, which was developed by Janssen, inhibits the activity of interleukin (IL)-12/23, a type of inflammatory cytokine related to autoimmune diseases, and is used to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

 

Annual global sales of the drug amount to approximately KRW 14 trillion.

 

Samsung Bioepis has successfully commercialized the first biosimilars in Korea in 3 areas this year.

 

In January, Samsung Bioepis obtained marketing authorization from the MFDS for Episcli, a Soliris biosimilar.

 

Soliris is a treatment for rare diseases such as paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome developed by Alexion, with global sales of approximately KRW 5 trillion.

 

Also, the company obtained marketing authorization for Eylea biosimilar Afilivu in February.

 

Eylea, which was developed by U.S.-based Regeneron, has indications for wet (neovascular) age-related macular degeneration.

 

Macular degeneration is an ocular disease caused by aging and inflammation of the retinal macula, the nerve tissue in the center of the retina of the eye.

 

In severe cases, it can cause blindness.

 

With Samsung Bioepis succeeding in commercializing the first biosimilars in three markets in Korea this year, domestic pharmaceutical and biotech companies have now received approval for biosimilars in a total of 11 areas.

 

Domestic companies first tapped into the biosimilar market in 2012 when Celltrion was granted approval for Remsima.

 

Remsima is a biosimilar product of Remicade, an autoimmune disease treatment.

 

Samsung Bioepis received MFDS approval for Remicade biosimilar Remaloce in 2015.

 

Korean pharma and biotech companies have been receiving approval for their biosimilar products in the Enbrel, Humira, Herceptin, Mabthera, Avastin, Lucentis, and Nesp markets.

 

In 2015, Samsung Bioepis received approval for its first biosimilar of Enbrel, Etoloce.

 

In the Enbrel market, LG Chem received approval for the second Enbrel biosimilar, Eucept in 2018.

 

Celltrion commercialized its second biosimilar, Herzuma, in 2014.

 

Herzuma is a Herceptin.

 

Herzuma was the first biosimilar of an anticancer drug that was released by a Korean company.

 

Samsung Bioepis entered the Herzuma market second in 2017 with the approval of its Samfenet.

 

In 2015, Celltrion received domestic approval for Truxima, a biosimilar of the anticancer drug Mabthera.

 

A total of 3 domestically developed biosimilars have been approved in the autoimmune treatment Humira market.

 

In July 2020, Samsung Bioepis received approval for Adalloce, the first Humira biosimilar, and Celltrion received approval for Yuflyma in June 2021.

 

LG Chem received approval for Xelenka in December of last year, which became the third new entrant into the Humira market.

 

Samsung Bioepis successfully commercialized its first biosimilar, Onbevzi, of the cancer drug Avastin in March 2021.

 

Avastin is an anticancer drug indicated for the treatment of metastatic colorectal and 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.

 

In September 2022, Celltrion received domestic approval for the second Avastin biosimilar, Vegzelma.

 

In 2022, 2 Lucentis biosimilars entered the domestic approval stage.

 

Lucentis is used to treat eye diseases such as macular degeneration and diabetic macular edema.

 

In May 2022, Samsung Bioepis received domestic approval for Amelivu, a biosimilar of Lucentis.

 

In October of the same year, Chong Kun Dang obtained a domestic license for Lucentis biosimilar LucenBS.

 

In 2018, Chong Kun Dang’s biosimilar Nesbell, a biosimilar of the anemia drug Nesp, reached the commercialization stage.

 

In total, 19 biosimilars from Korean companies have been approved as of now.

 

By company, Samsung Bioepis had the most biosimilars with 9, and Celltrion entered 6 markets.

 

LG Chem and Chong Kun Dang each released 2 biosimilars.