Samsung Bioepis and partner Merck announced on 4 December 2015 that Samsung Bioepis had received approval for its infliximab biosimilar Renflexis from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).
Korean approval for infliximab biosimilar
Biosimilars/News | Posted 11/12/2015 0 Post your comment
Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis. Renflexis has been approved in Korea for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis in adults (≥ 18 years).
Merck will commercialize Renflexis in Korea as part of Merck’s commercialization partnership with Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen. Merck plans to launch Renflexis in South Korea in the first half of 2016.
Merck and Samsung Bioepis made a deal to develop and commercialize biosimilars back in February 2013 [1]. This was expanded in February 2014 to include biosimilar insulin [2] and now covers infliximab, etanercept, adalimumab, trastuzumab and insulin glargine. The Korean MFDS approved Brenzys (etanercept), another biosimilar covered by the Merck/Samsung Bioepis partnership, on 8 September 2015 [3].
Celltrion was the first to gain European approval for infliximab (Remsima/Inflectra), as the world’s first monoclonal antibody biosimilar and as part of its collaboration with US-based generics major Hospira [4]. Samsung Bioepis submitted its biosimilar infliximab for European Medicines Agency’s (EMA) approval in March 2015 [5]. In November 2015, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the company’s biosimilar etanercept product (SB4) [6].
Related article
Biosimilars approved in South Korea
References
1. GaBI Online - Generics and Biosimilars Initiative. Merck makes biosimilars deal with Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Merck-makes-biosimilars-deal-with-Samsung-Bioepis
2. GaBI Online - Generics and Biosimilars Initiative. Merck and Samsung Bioepis collaborate on biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Merck-and-Samsung-Bioepis-collaborate-on-biosimilar-insulin
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-etanercept-approved-in-South-Korea
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis submits second biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-submits-second-biosimilar-to-EMA
6. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-etanercept-biosimilar
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.
Source: Merck, Samsung Bioepis
Research
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
General
Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
SBR issues consensus on interchangeability of reference products and biosimilars
Comments (0)
Post your comment