South Korean biotechnology company Celltrion announced that it had received approval for its non-originator infliximab, Remsima, from Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav) on 13 July 2015.
The drug is a biosimilar of Johnson & Johnson’s blockbuster anti-inflammatory treatment Remicade (infliximab), which is indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
Celltrion has partnered with Russian pharma company EGIS, one of the leading pharmaceutical companies in Central and Eastern Europe. EGIS will be in charge of sales in the Russian Federation and the product will be marketed under the name Flammegis in the country.
The Russian approval has been a long time coming, taking about two and a half years since Celltrion submitted its application for Remsima in January 2013. Russia is not the easiest country to export to. The country has stringent requirements and complicated procedures and also has a requirement for clinical trials to be conducted on Russians within the country in order to register medicinal products in Russia. However, Russia is one of the most important countries for medicine export, as it has the largest economy among the Commonwealth of Independent States (CIS), a large pharmaceutical market, and a strong influence on neighbouring countries.
The market available for Remsima is estimated to be worth US$72 million, which is not big compared to the size of the economy. However, Russia is a ‘pharmerging’ country, with its drug market growing at 10–15% per year.
Celltrion gained European approval for the world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) as part of its collaboration with US-based generics major Hospira [1]. Since then, Celltrion has also gained approval for Remsima in South Korea [2], Colombia [3], Japan [4] and Canada [5]. Celltrion also filed a biosimilar application for its biosimilar infliximab (CT-P13) in the US back in August 2014, claiming it to be the first monoclonal antibody application to be filed in the US [6]. Brazil also approved Remsima, as its first follow-on biological medicine, through its pathway for follow-on biological products, in April 2015 [7].
Remsima is currently available in seven out of 10 CIS countries, and once sales start in Russia, Remsima can be prescribed in all CIS countries except for Kyrgyzstan and Tajikistan.
Editor’s comment
It should be noted that ‘non-originator biologicals’ approved in Russia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea
3. GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab launched in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-infliximab-launched-in-Japan
5. GaBI Online - Generics and Biosimilars Initiative. Infliximab SEB launched in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-SEB-launched-in-Canada
6. GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. Brazil approves first monoclonal antibody follow-on biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Brazil-approves-first-monoclonal-antibody-follow-on-biological
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Source: Business Korea, EGIS, Rosminzdrav
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