The Biosulin equivalence in standard therapy (BEST) study − a multicentre, open-label, non-randomised, interventional, observational study in subjects using Biosulin 30/70 for the treatment of insulin-dependent type 1 and type 2 diabetes mellitus

Abstract

Introduction.The need for more cost-effective insulin therapy is critical in reducing the burden on patients and health systems. Biosimilar insulins have the potential to dramatically lower healthcare costs by delivering insulin with a similar anti-glycaemic effect and adverse reaction profile. Objectives. The purpose of this study was to confirm equivalence in glycaemic outcomes and side-effect profiles between Biosulin 30/70 and other human premixed insulin preparations on the South African market in a clinical practice setting. Methods. Subjects in this interventional, observational, multicentre, open-label, prospective study were switched from their existing human premix insulin (Actraphane, Humulin 30/70 or Insuman) to the study insulin Biosulin 30/70. The primary endpoint was the change in HbA1c from baseline to 6 months. Results. Seventy-seven adult patients with type 1(n=18) or type 2 (n=59) diabetes were enrolled. The baseline HbA1c in the overall cohort was 7.9%, 8.0% at 3 months (p=0.50) and 7.6% at 6 months (p=0.14).There was a small increase in the total daily dose of insulin used in both the type 1 and type 2 cohort, from 0.62 to 0.65 units/kg/day (p=0.0004). There was no significant difference in weight in the study subjects during the 6-month period on Biosulin 30/70 (p=0.67). Conclusion. Biosulin 30/70 achieved at least equivalent glycaemic control to existing human premix insulins, with no reported new or severe adverse events. Increased use of biosimilar insulins has the potential for significant cost savings.

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review

“…Post-switch dose increase to maintain target Hb: 46% of patientsNRNRMorosetti et al 2017 [79] a With chronic renal failure ( N  = 87)87ESA, 6 monthsBiosimilar, 6 monthsPre- vs post-switch Hb, ferritin, transferrin saturation: all P NS; mean monthly epoetin consumption/patient: 52,460 vs 49,517 Ul ( P NS)No changes in incidence of thrombosis or cardiovascular eventsNRBalili et al 2015 (abstract) [83]With T2DM ( N  = 24)24Humulin 70/30, duration NRWosulin 70/30, duration NRPre- to post-switch mean HbA1c decreased by 1.3%, total insulin dose/day increased by 2.4 units. Target HbA1c was achieved (specific results NR)NRNRSegal et al 2013 [87]With T1DM or T2DM ( N  = 77)77Actraphane, Humulin 30/70 or Insuman, insulin duration 7 yearsBiosulin 30/70, 6 monthsBaseline (at switch) vs post-switch: no significant change in HbA1c, neither overall nor in subgroups by type of diabetes; small, significant increase in insulin doseNo severe hypoglycaemic episodes reported; other details NRNRFlodmark et al 2013 [88] (comment: Ekelund et al 2014 [134])With growth disturbances ( N  = 98)98Genotropin RP, duration NR (graph suggests up to 2 years)Omnitrope ® , duration NR (graph suggests up to 1.5–2 years)Growth in height after switch: modelled vs actual data suggest no impact of switch on growthNumber of patients with TEAEs in 12 months after switch: 18 patients; injection site pain: 18 (of whom 6 subsequently switched back to originator preparation)NRGila et al 2014 (abstract) [89]With growth disturbances ( N  = 20)20rhGH RP, mean duration 38 monthsOmnitrope ® , follow-up 36 monthsHeight velocity, 18 months before switch: 9 ± 2 cm/year; at switch: 6 ± 1 cm/year; 18 months after switch: 7 ± 3 cm/year (statistical analysis NR)No TEAEs reported after switch; 3 patients had transitory problems with Omnitrope ® deviceNRRashid et al 2014 [90]With growth disturbances ( N  = 103)…”

Diabetes care in South Africa: A tale of two sectors

“…Additionally, the significant intra-and inter-patient patient variability seen when using NPH insulin makes it unlikely that the HbA1c data in Segal et al's clinical trial [1] accurately reflect the quality of glycaemic control in these patients. The population of Diabetes care in South Africa: A tale of two sectors type 1 patients was sourced mainly from the state sector, and they were not provided with the means to perform any self-monitoring of blood glucose.…”

“…Two papers [1,2] in this issue of SAMJ clearly reveal the polar ends of the diabetes treatment spectrum. One deals with the provision of insulin pumps to a group of well-controlled young people who are undoubtedly fully acquainted with this technology and who also receive their care in the private (self-funded) sector.…”

“…By implication, the previously held notion that 'one size fits all' may need to be abandoned. Segal and colleagues [1] correctly state that treating diabetes is costly and consumes large resources, in terms of both treatments and personnel. In Africa, diabetes is fast emerging as an important noncommunicable disease.…”

“…In their paper, the Biosulin equivalence in standard therapy (BEST) investigators are careful to point out the differences between generic and bio-identical/similar products. [1] It appears from their small study that, using an inexpensive insulin and relying on HbA1c data alone in the absence of regular self-monitoring of blood glucose, a person with diabetes can 'get by' . This would appeal to health economists and would certainly fulfil some of the needs of the continent.…”