Korean companies Samsung Bioepis and Celltrion have accelerated their penetration into the global market, with a total of 11 approvals in Europe and eight in the US. In addition, Korea’s LG Chem has expanded its presence in Japan and China. This growth follows increasing investment in the biotech sector from South Korea’s government and private pharmaceutical companies [1, 2].
Remsima, an infliximab biosimilar of originator Remicade, was Celltron’s first biosimilar approved in Europe in 2013 [3]. In recent years, Celltrion also received approval of several biosimilars in Europe: Remsima SC (Remicade), Truxima (MabThera), Herzuma (Herceptin) and Yuflyma (Humira); and four in the US including: Remsima (Remicade), Truxima (MabThera) and Herzuma (Herceptin). The company is also conducting additional phase III clinical trials for Remsima SC (Remicade) and Yuflyma (Humira) for approval in the US.
Samsung Bioepis has recently obtained sales approval for Byooviz, a Lucentis biosimilar, in the US and EU. Lucentis is sold by Roche and Novartis and is a treatment for eye diseases, such as macular degeneration. This joins five other biosimilars approved in Europe: Benepali (Enbrel), Flixabi (Remicade), Imraldi (Humira), Ontruzant (Herceptin) and Aybintio (Avastin), and four in the US: Eticovo (Enbrel), Renflexis (Remicade), Hadlima (Humira) and Ontruzant (Herceptin).
LG Chem expanded into the Japanese market with rheumatoid arthritis treatment, Eucept. Eucept is a biosimilar version of Pfizer's Enbrel and is sold at prices that average 30% less than the originator. LG Chem also plans to launch an adalimumab biosimilar in Japan following its approval in March 2021 [4]. This is an autoimmune disease treatment and a biosimilar of originator Humira. LG Chem expanded into the Chinese market in 2013 with its bioproduct, hyaluronic acid filler, Yvoire. This is now also sold in 44 countries across the globe.
Note: For all biosimilars mentioned originator brand name follows in ()
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References
1. GaBI Online - Generics and Biosimilars Initiative. South Korea increases investment in biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/Biosimilars/General/South-Korea-increases-investment-in-biologicals
2. GaBI Online - Generics and Biosimilars Initiative. Approved biosimilars for South Korean firms Celltrion and Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/biosimilars/general/approved-biosimilars-for-south-korean-firms-celltrion-and-samsung-bioepis
3. GaBI Online - Generics and Biosimilars Initiative. EMA approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/biosimilars/news/EMA-approves-first-monoclonal-antibody-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. LG Chem gains approval for adalimumab biosimilar in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 12]. Available from: www.gabionline.net/biosimilars/news/LG-Chem-gains-approval-for-adalimumab-biosimilar-in-Japan
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