The last few years have seen biosimilars the hot topic on the agenda of most countries. This is evidenced by the increasing number of biosimilars manufacturers as well as approvals for biosimilars around the world [1].
The period of 2012 to 2014 has seen biosimilars increasingly on the agenda globally, with Europe once again leading the way. Just some of the major biosimilars events that have taken place in 2012 to 2014 are shown in Figure 1.
Figure 1: Biosimilars events in the period 2012 to 2014
Teva received US Food and Drug Administration (FDA) approval for Tbo-filgrastim (Granix) on 29 August 2012. Granix was filed in the US as a Biologics License Application (BLA) since a biosimilar approval pathway had not been established at the time of submission [2]. A biosimilars pathway was established in the US via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). FDA has recently accepted its first application via the biosimilars pathway for Sandoz’s biosimilar filgrastim product [3].
South Korea has been steaming ahead with two biosimilars approved in recent years, both from South Korean biologicals specialist Celltrion. Remsima (infliximab) was approved in July 2012 [4] and Herzuma (trastuzumab) was approved in January 2014 [5] by the Korean Ministry of Food and Drug Safety (MFDS).
Japan approved its second biosimilar granulocyte colony-stimulating factor (G-CSF), Filgrastim NK, produced by Nippon Kayaku and development partner Teva Pharmaceutical Industries (Teva) in February 2013. Japan approved its first biosimilar G-CSF (Filgrastim BS) in November 2012 [6].
Once again, Europe has been leading the way with the landmark decision on 27 June 2013 by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) to recommend approval of the infllximab biosimilars Inflectra and Remsima, proving that the biosimilar concept can be successfully applied to such complex molecules as monoclonal antibodies [7].
In January 2014, EMA’s CHMP also recommended the granting of a marketing authorization for biosimilar infertility treatment Bemfola (follitropin alfa) [8].
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Related articles
Biosimilars approved in South Korea
Biosimilars approved in Europe
References
1. Sheppard A. Biological/biotechnological and biosimilars market: the global outlook with special focus on Europe. 12th EGA International Biosimilar Medicines Conference; 3-4 April 2014; London, UK.
2. GaBI Online - Generics and Biosimilars Initiative. Teva launches new biologicals in Europe and US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Teva-launches-new-biologicals-in-Europe-and-US
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts biosimilar filgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-biosimilar-filgrastim-application
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-approved-in-Korea
6. GaBI Online - Generics and Biosimilars Initiative. Japan approves second biosimilar G-CSF [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Japan-approves-second-biosimilar-G-CSF
7. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
8. GaBI Online - Generics and Biosimilars Initiative. EMA approves follitropin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-follitropin-alfa-biosimilar
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