Cuban human recombinant erythropoietin (ior® EPOCIM): 25 years from the manufacturer's point of view
Keywords:
erythropoietin, biotechnology, renal chronic disease, intersectoral collaboration, social changeAbstract
Introduction: In 1989, recombinant human erythropoietin was approved for correction of anemia in chronic kidney patients, one of the technological advances applied to health with high medical and social impact, high cost and restricted access for Cubans. This resulted in a state willingness to develop and obtain a Cuban erythropoietin: ior® EPOCIM.
Objective: Describe the challenges and opportunities from the perspective of manufacturer in 25 years.
Methods: documentary references were taken from annual reports, periodic product safety reports and interviews with managers from Center for Molecular Immunology.
Development: Relevant historic events of this medicine was described from the productive technological challenge, clinical research, international collaboration, regulatory challenge and the social and economic impact.
Conclusions: the social commission granted to this Cuban biotechnology company led to the construction of a dynamic model of technological updating, health research, marketing and adjustments to regulatory requirements to continue providing a quality, safe and effective essential medicine, with health impact for Cuban people and other countries; achieving an economically sustainable investment. An example of success about the capacity of the national biopharmaceutical industry to achieve a medicine with technological sovereignty.
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