11 years since global entry…K-biosimilars

received 15 European and 12 U.S. approvals

This year, Celltrion·Samsung Bioepis received 3 approvals in Europe and the United States

Following the European approval of Remsima in 2013, Celltrion received 6 approvals in Europe and 5 approvals in the United States

Samsung Bioepis received the first European approval of Benepali in 2015…received 6 approvals in Europe and 8 approvals in the United States

The biosimilar products developed by Korean companies are actively tapping into the global market.

 

Celltrion received approval for Remsima in Europe in 2013.

 

Since then, Koran companies have successfully commercialized 15 products in Europe and 12 products in the United States for the past 11 years.

 

Celltrion secured 11 approvals in Europe and the United States, and Samsung Bioepis accomplished 14 approvals.

 

According to industry sources on May 27th, Celltrion and Samsung Bioepis’ biosimilars received three approvals from Europe and the United States.

 

On May 24th, Celltrion received the European Commission (EC) approval for its Omlyclo, a biosimilar to Xolair.

 

The official approval was granted in two months, after the company received an approval recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in March.

 

Omlyclo is the first Xolair biosimilar to receive European approval.

 

Xolair is a biosimilar antibody used for persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria.

 

It recorded KRW 5 trillion in global sales last year.

 

In Omlyclo’s global Phase 3 trials, which enrolled 619 patients with chronic spontaneous urticaria across six European countries, Celltrion demonstrated Omlyclo’s equivalent efficacy to the original medicine and confirmed a similar safety profile.

 

In two years since receiving approval for Vegzelma, a biosimilar to Avastin, in 2022, Celltrion established an additional biosimilar pipeline.

 

This year, Samsung Bioepis received approval for its biosimilar both in Europe and the United States.

 

Samsung Bioepis received EC approval for Pyzchiva, Stelara’s biosimilar.

 

The company received the final approval for Pyzchiva two months after receiving a positive review for approval from the EMA’s CHMP in February.

 

Stelara, developed by Janssen, is prescribed for treating autoimmune diseases, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

 

It inhibits the activities of the immune response-associated inflammatory cytokine called interleukin (IL)-12 and 23.

 

The annual global sales amount to approximately KRW 1.4 trillion.

 

Samsung Bioepis added the product to its portfolio after receiving approval for Soliris biosimilar, Epysqli, in Europe in May last year.

 

Samsung Bioepis received approval from the U.S.

 

FDA for its Opuviz, a biosimilar to the macular degeneration drug Eylea.

 

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

 

Eylea’s global sales last year amounted to approximately KRW 1.3 trillion.

 

This marks the approval of Samsung Bioepis’ biosimilar in three years, following the approval of Byooviz, a biosimilar to Lucentis, in 2021.

 

Korean biosimilar products granted approvals in Europe and the United States.

 

Celltrion’s Remsima, a biosimilar to Remicade, and others.

 

Samsung Bioepis’ Benepali, a biosimilar to the autoimmune disease treatment Enbrel, and others.

The current list of global entries by companies show that Celltrion has received six approvals in Europe and five approvals in the United States.

 

Celltrion received the marketing authorization in Europe for its Remsima, titled ‘world’s first biosimilar antibody,‘ in August 2013.

 

Subsequently, Celltrion received European approval for Truxima, a biosimilar to Mabthera, in 2017 and Herzuma, a biosimilar to Herceptin, in 2018.

 

These drugs are immunotherapy for cancer.

 

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

 

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

 

In February 2021, Celltrion obtained European approval for its Yuflyma, a biosimilar to Humira.

 

In August 2022, Celltrion obtained European marketing authorization for its Vegzelma, a biosimilar to Vystin.

 

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

 

In 2018, Truxima and Herzuma received FDA approval.

 

In September 2022, Celltrion obtained 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 marketing authorization for Zymfentra, a subcutaneous (SC) formulation of the biosimilar antibody Remsima, as a novel drug.

 

Samsung Bioepis accomplished eight approvals in Europe and six approvals 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.

 

In May of the same year, Samsung Bioepis also obtained marketing authorization in Europe for its biosimilar Flixabi, a biosimilar to the autoimmune disease treatment Remicade.

 

In 2017, Samsung Bioepis received European approvals for its biosimilars to Herceptin, an immunotherapy for cancer, and Humira, an autoimmune disease medication.

 

In 2020, the company successfully acquired European approval for its biosimilar to Avastin, and in 2021, it also received a marketing authorization for a biosimilar to Lucentis, an eye disease medication, in Europe.

 

In May last year, Samsung Bioepis obtained marketing authorization from the EC for ’Episcli,’ a biosimilar to the orphan drug ’Soliris.’ Episcli is the first biosimilar developed by Samsung Bioepis in hematology.

 

Soliris, developed by Alexion Pharmaceuticals, is a high-cost medication for refractory rare diseases such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

 

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

 

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

 

In January 2019, Ontruzant, a biosimilar to Herceptin, received 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.

 

Koran companies have successfully commercialized 15 products in Europe and 12 products in the United States for the past 11 years, following Celltrion’s European approval for Remsima in 2013.

 

The companies strengthened global targeting, entering over two products annually into the United States and Europe.