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Venezuelan approval for Celltrion’s Remsima Posted 08/05/2015

Celltrion announced on 29 April 2015 that it had received approval for its infliximab bioterapéuticos similares from the Venezuelan medicines agency, the Instituto Nacional de Higiene ‘Rafael Rangel’ (INHRR National ‘Rafael Rangel’ Institute of Hygiene).

This latest approval follows that of Brazil [1], and means that South Korean biosimilars maker Celltrion now has approval to sell Remsima in 13 out of the 22 countries in South America. The approvals include the huge markets of Brazil and Mexico, which account for nearly 80% of the South American pharmaceuticals market. This therefore opens up a tumour necrosis factor (TNF)-alpha inhibitors market worth an estimated US$1.6 billion in total.

Venezuela has a population of approximately 30 million and the TNF-alpha inhibitor market for medicines like Remsima in the country is estimated to be worth about US$400 million. And more importantly the country is the leading power of Mercosur, a sub-regional block comprising 12 South American countries, which includes Argentina, Chile and Uruguay. Mercosur arranges free trade and economic cooperation in South America, making Venezuela a strategically important country for Remsima to expand its South American presence.

Venezuela introduced guidelines for bioterapéuticos similares (similar biotherapeutics) in 2012 [2].

Latin American partner Oli-Med, which sells medicines in 18 countries in South America, will take charge of Remsima sales in Venezuela. Celltrion has also stated that it has signed five out-licensing agreements for the regions of China, Korea, Taiwan, Peru and nine other countries, as well as Venezuela.

Editor’s comment
It should be noted that bioterapéuticos similares approved in Venezuela 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.

Related article
Similar biotherapeutic products approved and marketed in Latin America

References
1.   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 May 8]. Available from: www.gabionline.net/Biosimilars/News/Brazil-approves-first-monoclonal-antibody-follow-on-biological 
2.   GaBI Online - Generics and Biosimilars Initiative. Venezuela issues draft guideline for bioterapéuticos similares [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 8]. Available from: www.gabionline.net/Guidelines/Venezuela-issues-draft-guideline-for-bioterapeuticos-similares 

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Source: Business Korea

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