K-similars won record number of U.S.·Europe nods this year

'30 approvals over 11 years'

Celltrion·Samsung Bioepis won 6 approvals this year…exceeding the previous 5 approvals in 2019

For 11 years, 30 products have been approved since Remsima launched in Europe in 2013…averaging 3 per year

Celltrion won 14 U.S.·Europe nods…Samsung Bioepis won 16 approvals

Korean biopharmaceutical companies have launched the highest number of biosimilars in history this year in the United States and European markets.

 

As Celltrion and Samsung Bioepis won approvals for six biosimilars over eight months in the world's largest market, they topped the previous record of five cases of five years ago.

 

According to sources on August 27th, Celltrion's SteQyma, a biosimilar to Stelara for the treatment of autoimmune diseases, received marketing authorization from the European Commission (EC).

 

It reached the final commercialization step two months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency's (EMA) committee issued a positive opinion recommending SteQyma approval at the end of June.

 

Stelara (ustekinumab), developed by Janssen, is a treatment for autoimmune diseases prescribed for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

 

It inhibits the activity of interleukin (IL)-12,23, a type of inflammatory cytokine involved in immune responses.

 

Last year, the global market size for ustekinumab was estimated at US$ 20.4 billion (about KRW 26.5 trillion).

 

The European market was estimated at US$3.1 billion (about KRW 4.0 trillion), taking 15% of the global market.

 

After Samsung Bioepis won European approval for Pyzchiva, a biosimilar to Stelara, in April, Celltrion entered the European market as the second Korean company.

 

In June, Samsung Bioepis obtained a marketing authorization for Pyzchiva.

 

U.S.

 

and European biosimilar approvals obtained by Korean biopharmaceutical companies: (2024) Celltrion won European approval for Omlyclo, a biosimilar to Xolair, and SteQyma, a biosimilar to Stelara in 2024.

 

Samsung Bioepis won European approval for Pyzchiva, a biosimilar to Stelara, and U.S.

 

FDA approval for Opuviz, a biosimilar to Eylea, Pyzchiva, and Epysqli, a biosimilar to Soliris in 2024 (source: respective companies and FSS).

Celltrion and Samsung Bioepis won six approvals for biosimilars in the United States and Europe this year.

 

It exceeded the previous record of five approvals in 2019, breaking the highest number of approvals in history.

 

Celltrion received a marketing authroziation for Omlyclo, a biosimilar to Xolair, from the EC in May.

 

Omlyclo is the first Xolair biosimilar to receive the European marketing authorization.

 

Xolair is an antibody biosimilar used to treat allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria (CSU).

 

Samsung Bioepis won four biosimilar approvals this year in the United States and Europe this year, with three approvals in the United States and one in Europe.

 

In April, Samsung Bioepis won European approval for Pyzchiva, a biosimilar to Stelara.

 

Since May, Samsung Bioepis succeeded in obtaining biosimilar approvals from the U.S.

 

FDA for the past three months.

 

It received approval for Opuviz, a biosimilar to Eylea.

 

Eylea, developed by Regeneron in the United States, is indicated for treating wet age-related macular degeneration (AMD).

 

Eylea generated approximately KRW 13 trillion in global sales last year.

 

After winning FDA approval for Pyzchiva in June, Samsung Bioepis obtained a marketing authorization for its orphan drug Epysqli.

 

Epysqli, developed by Alexion in the United States, is a biosimilar to Soliris.

 

Epysqli won FDA approval as a treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

 

In 2019, Celltrion and Samsung Bioepis received five biosimilar approvals in the United States and Europe.

 

In November 2019, Celltrion received European approval for Remsima SC, a subcutaneous injection formulation of Remicade.

 

Remsima SC is a biosimilar developed by Celltrion by changing the formulation of Remicade from intravenous (IV) to subcutaneous (SC) injection.

 

In 2019, Samsung Bioepis received FDA approval for four biosimilars to Herceptin, Enbrel, Humira, and Lucentis.

 

In January 2019, Ontruzant, a biosimilar to Herceptin, received a marketing authorization in the United States, followed by Eticovo and Hadlima, biosimilars to Enbrel and Humira, in April and July of the same year, respectively.

 

Samsung Bioepis obtained FDA approval for its Byooviz, a biosimilar to Lucentis, in the United States in September 2021.

 

Korean pharmaceutical companies have started actively targeting the global biosimilar market after Celltrion's Remsima received European marketing authorization under the title of 'The world's first antibody biosimilar' in August 2013.

 

Since 2016, Korean biopharmaceutical companies continued to win new approvals yearly in the United States and Europe.

 

Celltrion achieved success, obtaining eight approvals in Europe and six in the United States.

 

The company also entered the European market for Remicade, Mabthera, Herceptin, Avastin, Humira, Xolair, and Stelara.

 

In 2016, Celltrion's Inflectra, a biosimilar to Remicade, became the first to win FDA approval in the United States.

 

In 2018, Truxima and Herzuma received FDA approvals.

 

In September 2022, Celltrion obtained a marketing authorization for Vegzelma, a biosimilar to Avastin, from the FDA, and last year, Yuflyma, a biosimilar to Humira, also received FDA approval.

 

In August last year, Celltrion received a marketing authorization for Zymfentra, a SC formulation of Remsima, as a novel drug.

 

Samsung Bioepis won eight approvals in Europe and six in the United States.

 

In January 2016, Samsung Bioepis began its global market expansion by obtaining approval for its Benepali, a biosimilar to the autoimmune disease treatment Enbrel, in Europe.

 

Afterward, the company received European approval for biosimilars referencing Remicade, Herceptin, Humira, Avastin, Lucentis, Soliris, and Stelara.

 

In April 2017, Samsung Bioepis received the first FDA approval in the United States for its Renflexis, a biosimilar to Remicade.

 

After that, the company entered the U.S.

 

market for biosimilars referencing Herceptin, Enbrel, Humira, Lucentis, Eyela, Stelara, and Soliris.