In a study of non-comparable biologics to erythropoietin, a biologic that stimulates red blood cell production, a high incidence of pure red cell aplasia (PRCA) was demonstrated in patients in Thailand. PRCA, a potentially deadly disease in which red blood cell development stops, was shown to be 14 times higher in Thailand than the average observed in markets with fewer available erythropoietin products.1
“[For the Thai population] Estimation of risk for anti-r-HuEpo-associated PRCA was calculated … 1 out of 2608 patients using biosimilar r-HuEpo would develop PRCA.” 2
Many other studies comparing a specific biologic from several less regulated countries around the world have demonstrated differences in product purity which underscores the high level of variability between biologics and forms the basis for requiring robust preclinical testing in-lab, and consistent high standards of quality control. These differences can potentially impact immunogenicity and patient safety, which is why high-quality product development and manufacturing managed by experienced scientists are critical to delivering high-quality biosimilars to patients.