Samsung Bioepis gets OK to sell Stelara biosimilar in Europe

The latest approval from the EC expands the company's portfolio of autoimmune disease treatments in Europe

Samsung Bioepis gets OK to sell Stelara biosimilar in Europe
Dae-Kyu Ahn 1
2024-04-23 11:06:10 powerzanic@hankyung.com
Bio & Pharma


South Korea's Samsung Bioepis has received approval from the European Commission to sell Pyzchiva, a biosimilar of the autoimmune disease Stelara. 

This approval came two months after the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) issued a positive opinion in February.

The latest approval increases the total number of the company's autoimmune disease biosimilars approved in Europe to four.

Sales of Pyzchiva in Europe will be managed by Samsung Bioepis' partner, Sandoz.

Stelara, a drug developed by the global pharmaceutical company Janssen, treats several conditions, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Samsung Bioepis currently markets a portfolio of seven commercialized biosimilars in Europe.

This portfolio comprises three treatments for autoimmune diseases (biosimilars of Enbrel, Remicade, and Humira), two oncology biosimilars (biosimilars of Herceptin and Avastin), one ophthalmic treatment (a biosimilar of Lucentis), and one for blood disorders (a biosimilar of Soliris).

Write to Dae-Kyu Ahn at powerzanic@hankyung.com

Samsung Bioepis to supply Hadlima to US government

Samsung Bioepis to supply Hadlima to US government

South Korea’s Samsung Bioepis and the US-based Organon, the local partner company of Samsung group's biopharmaceutical research and development unit, have secured a bid to supply its biosimilar Hadlima (adalimumab-bwwd), a treatment for autoimmune diseases, to the US Department of Vetera

Samsung Bioepis gets FDA OK for its interchangeable biosimilar

Samsung Bioepis gets FDA OK for its interchangeable biosimilar

Byooviz, a biosimilar of the macular degeneration treatment Lucentis and made by South Korea’s Samsung Bioepis, has received official designation from the US Food and Drug Administration (FDA) as interchangeable with the original medicine. Samsung Bioepis is thus South Korea’s fi

Samsung Bioepis to cooperate with Swiss firm Sandoz

Samsung Bioepis to cooperate with Swiss firm Sandoz

Samsung Bioepis headquarters  Samsung Bioepis Co., a biopharmaceutical research and development unit under South Korea's Samsung Group, announced on Monday that it signed a partnership agreement with Swiss pharmaceutical company Sandoz for sales of autoimmune disease treatment Stelara (act

Samsung Bioepis seeks to buy Biogen biosimilar unit

Samsung Bioepis seeks to buy Biogen biosimilar unit

Researcher at Samsung Bioepis' laboratory (Courtesy of Samsung) Samsung Bioepis Co., a biopharmaceutical research and development unit under South Korea’s Samsung Group, seeks to buy a biosimilar business division of Nasdaq-listed Biogen Inc. at less than 1 trillion won ($775.3 million),

(* comment hide *}