Amgevita approved in Colombia Posted 17/04/2020

Colombia’s National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos) has approved the first adalimumab producto bioterapéutico similar (similar biotherapeutic product).

Amgen’s Amgevita (ABP 501) is the first producto bioterapéutico similar to be approved in Colombia for the treatment of complex diseases such as rheumatoid arthritis, Crohn’s disease and psoriasis.

ABP 501 was approved as Amjevita (adalimumab-atto) in the US in September 2016 [1] and was approved in Europe as Amgevita in March 2017 [2].

Amgevita has been 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.

According to the Ministry of Health and Social Protection, of the 10 most used medicines in the Colombian healthcare system, eight are biologicals and are mainly intended for the treatment of complex diseases.

If there were just two competitors for each of those eight biologicals, the Colombian healthcare system could save US$600,000 million. It is for this reason that the entry of biosimilars into the country represents an important contribution to the financial sustainability of the healthcare system.

INVIMA has also approved producto bioterapéutico similares for enoxaparin sodium (Clenox, Nurox, Noxarin, Clasina, Enoxalow and Enoxpar), epoetin alfa (Eritina, Eritromax, Eritropoyetina Humana Recombinante, Epoyet and Heberitro), etanercept (Etanar), filgrastim (Zarzio, Biofigran, Leucosos, Neulastim, Hebervital, Genfilgras, Nufil Safe and Valgrastim), infliximab (Remsima), insulin glargine (Basaglar and Podevta), somatropin (Omnitrope, Humatrope, Norditropin, Nordilet, Saizen, Zomacton and Groetropin) and teriparatide (Osteotide).

Related articles
Biosimilars of adalimumab

Similar biotherapeutic products approved and marketed in Latin America

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: INVIMA, RedMas

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