Comparability in efficacy and similarity in safety between Insulin Glargine Biosimilar（hereinafter referred to as FFP-112）and Lantus^® were investigated in Japanese patients with type 1 diabetes mellitus on intensive insulin therapy.
　　A total of 260 subjects was administered the investigational drug（131 treated with FFP- 112 and 129 treated with Lantus^®）. Hemoglobin A1c（HbA1c）change from baseline to week 24（mean±standard deviation）as the primary endpoint was −0.01±0.54％ in FFP-112 and −0.05±0.62％ in Lantus^®. The estimated difference in adjusted mean（95％ confidence interval） for FFP-112 compared with Lantus^® was 0.03％（−0.10 to 0.17）. This result met the prespecified criteria for equivalence（−0.45 to 0.45）, demonstrating that FFP-112 is equivalent to Lantus^®.
　　Secondary endpoints of efficacy were the changes in HbA1c, fasting blood glucose before breakfast, 7-point self-monitored blood glucose and basal-bolus insulin regimen. Secondary endpoints of safety included adverse events, adverse drug reactions, hypoglycemia, incidence of anti-insulin glargine and anti-insulin antibodies, and other test parameters. These analyses showed that each of secondary endpoints was not largely different clinically between FFP-112 and Lantus^® throughout the study period, indicating similarities between the two products.
　　The results above demonstrate that FFP-112 is comparable to Lantus^® in efficacy, showing that FFP-112 can provide comparable glyceamic control at doses similar to Lantus^® doses. Thus, as with Lantus^®, FFP-112 is expected to provide long-term stable glyceamic control when administered in combination with bolus insulin. It is also shown that FFP-112 and Lantus ^® have a similar safety profile. It is thus concluded that FFP-112 is a useful treatment for patients with diabetes mellitus for whom insulin therapy is indicated.