12 Korean biosimilars globally approved in 3 months

The most amount of global approvals ever

Last year's record of 11 approvals was surpassed in just 3 months

8 biosimilar approvals for Celltrion and 4 for Samsung Bioepis in the U.S. and Europe

Celltrion totals at 24 approvals...Samsung Bioepis totals at 21 approvals

Domestic pharma and biotech companies have achieved 12 biosimilar approvals in the U.S.

 

and Europe this year.

 

Celltrion and Samsung Bioepis have surpassed last year's record of 11 approvals in three months due to their rapid global expansion.

 

Together, Celltrion and Samsung Bioepis have received over 20 biosimilar approvals in Europe and the United States.

 

Celltrion received the U.S.

 

Food and Drug Administration (FDA) approval for Xolair’s biosimilar Omlyclo on the.

 

10, according to industry sources.

 

Xolair is an antibody biologic drug used to treat allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria.

 

Xolair generated global sales of approximately KRW 6 trillion last year.

 

Omlyclo is the first Xolair biosimilar to be approved in the U.S.

 

and was also the first to be approved in other major global markets including the European Commission (EC), South Korea, the United Kingdom, and Canada.

 

Celltrion has now received approval for a total of 4 biosimilars in the U.S.

 

this year.

 

In January, Celltrion received FDA approval for Avtozma, a biosimilar version of the autoimmune disease treatment Actemra.

 

Actemra is indicated for rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and COVID-19.

 

On April 4, Celltrion received FDA approval for the biosimilars Stoboclo and Osenvelt, which are biosimilar versions of Prolia and Xgeva.

 

Prolia and Xgeva are biologics developed by Amgen that differ in the dose and dosing schedule of denosumab.

 

Prolia is approved for the treatment of osteoporosis and Xgeva is approved for the prevention of skeletal-related events in patients with bone metastases and the treatment of giant cell tumors of bone.

 

Number of biosimilars approved by domestic pharmaceutical and biotechnology companies in Europe and the United States by year (Unit: number of items, Source: each company, Financial Supervisory Service)

Celltrion has also received 4 biosimilar approvals in Europe this year.

 

Last month, Celltrion received biosimilar approvals for 4 original drugs: Eylea, Actemra, Prolia, and Xgeva.

 

Eylea is indicated for the treatment of ophthalmic conditions including wet macular degeneration, retinal vein occlusion macular edema, and diabetic macular edema.

 

Celltrion received a recommendation for approval of the 4 biosimilars from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in December of last year and cleared the final approval hurdle within 2 months.

 

This brings the total number of biosimilar approvals Celltrion has received in the U.S.

 

and Europe in the first 3 months of this year to 8, the most ever.

 

This more than doubles the 3 approvals it has received in 2018 and last year in just 3 months.

 

Samsung Bioepis has received a total of 4 biosimilar approvals in the U.S.

 

and Europe this year.

 

Last month, Samsung Bioepis received approvals for 2 biosimilar products Prolia and Xgeva in the U.S.

 

and Europe, respectively.

 

The Prolia biosimilar was approved under the brand name Ospomyv in the U.S.

 

and Obodence in Europe.

 

The Xgeva biosimilar was approved under the brand name Xbryk in both the U.S.

 

and Europe.

 

Celltrion and Samsung Bioepis have received approvals for a total of 12 biosimilars in the U.S.

 

and Europe this year.

 

This surpassed the previous record of 11 approved in a year last year in just 3 months.

 

Last year, 4 domestic pharma and biotech firms achieved 11 biosimilar approvals in the U.S.

 

and Europe.

 

Samsung Bioepis won 3 and 2 biosimilar approvals in the U.S.

 

and Europe, respectively, last year.

 

Samsung Bioepis received U.S.

 

approval for its Eylea biosimilar Opuviz in May last year.

 

In June and July last year, the company received FDA approval for its Stelara biosimilar Pyzchiva and Soliris biosimilar Epysqli, respectively.

 

Samsung Bioepis' Stelara biosimilar Pyzchiva and Eylea biosimilar Opuviz passed through the European gateway in April and November last year.

 

Celltrion received a total of 3 biosimilar approvals in the U.S.

 

and Europe last year.

 

Celltrion's biosimilar to Stelara received FDA approval last year, and biosimilars of Xolair and Stelara reached the commercialization stage in Europe.

 

Dong-A ST won back-to-back FDA approvals in the U.S.

 

and Europe for its biosimilar Imuldosa last year.

 

Korean biopharmaceutical company Prestige Biopharma obtained marketing authorization for its Herceptin biosimilar Tuznue in Europe in September last year.

 

In 2019, Celltrion and Samsung Bioepis received a total of 5 biosimilar approvals in the U.S.

 

and Europe.

 

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

 

Remsima SC is a subcutaneous (SC) version of the original intravenous (IV) formulation of Celltrion's proprietary biological drug, Remsima.

 

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

 

In January 2019, the company received U.S.

 

marketing approval for Herceptin biosimilar Ontruzant, followed by Ethicobo and Hadlima in April and July.

 

The original versions of Ethicobo and Hadlima are Enbrel and Humira, respectively.

 

In September 2021, Samsung Bioepis received U.S.

 

approval for Lucentis' biosimilar Byooviz.

 

In August 2013, Celltrion's Remsima was approved for sale in Europe as the world's first antibody biosimilar, marking the beginning of domestic biosimilars' push into the global market.

 

Since 2016, domestic pharma and biotech companies have continued to achieve new biosimilar approvals in the U.S.

 

or Europe every year.

 

Celltrion and Samsung Bioepis received 24 and 21 approvals in the U.S.

 

and Europe, respectively.

 

Celltrion received 12 and 12 approvals in Europe and the U.S., respectively.

 

Samsung Bioepis' biosimilars received 11 approvals in Europe and 10 in the US.