Remsima approved in Colombia

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Remsima approved in Colombia

Biosimilares/Novedades | Posted 10/01/2014 0 Post your comment

On 16 December 2013, Colombia’s National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos Y Alimentos) announced the approval of Remsima (infliximab) – the first producto bioterapéutico similar (similar biotherapeutic product) to be approved in Colombia.

South Korean biotechnology company Celltrion developed the biosimilar monoclonal antibody infliximab in collaboration with its partner Hospira. The two companies gained European approval for Remsima (Celltrion) and Inflectra (Hospira) in September 2013 [1].

The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) released a new draft guideline for biologicals, including biosimilars, in January 2013 [2]. The guideline provides for a ‘comparability pathway’ that permits approval of a producto bioterapéutico similar based on a comparison to a reference biotherapeutic product.

The Colombian approval of Remsima has been granted to Amarey Nova Medical by INVIMA – the equivalent to US Food and Drug Administration – which comes under the Colombian Ministry of Health and Social Protection. Remsima is approved in Colombia for the indications of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis – the same as those covered by the European approval.

Colombia has the fourth smallest pharmaceutical market in the Latin America region. Despite this fact, in 2012, the pharmaceutical market was worth US$4.23 billion. The market value is also expected to increase due to the fact that Colombia is looking to increase drug access for the whole population under its universal insurance programme.

Editor’s comment
It should be noted that productos bioterapéuticos similares approved in Colombia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA 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.

References

1. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 10]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar

2. GaBI Online - Generics and Biosimilars Initiative. Colombia issues draft decree for registration of biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 10]. Available from: www.gabionline.net/Guidelines/Colombia-issues-draft-decree-for-registration-of-biologicals

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Source: INVIMA