The advent of biosimilars for the treatment of diabetes: current status and future directions

Abstract

Biosimilar insulins are likely to enter the market of diabetes therapies as patents for major branded insulin products start to expire in the next few years (on June 2014, the European Medicines Agency authorized the first biosimilar of insulin glargine, Abasria, 100 Units/ml, for the treatment of diabetes mellitus). This would allow providing comparable clinical benefits of the current available insulins at a significantly lower cost, thus increasing the affordability and access of insulin treatment for patients with diabetes. Biosimilars are approved via a stringent regulatory pathway demonstrating quality, safety, and efficacy comparable to the reference product. However, the production complexities of such products raise important considerations for treatment efficacy and patient safety, including naming and product tracking, substitution practices, and pharmacovigilance. Additionally, as practitioners' knowledge regarding the differences about pharmacological, clinical, and regulatory aspects between biosimilars and generic small molecules is often suboptimal, specific education on biosimilar prescribing, dispensing, and administering is critical for ensuring patients' benefit and safety. This article discusses all the issues concerning biosimilar, especially biosimilar insulins.

RNA N6-methyladenosine: a promising molecular target in metabolic diseases

“…In the past decades, the various treatments were used to prevent and treat the aforementioned MDs but they are still limited [29]. For diabetes, the long term treatment is insufficient for controlling blood glucose by daily medicines take like metformin or subcutaneous injection of insulin, as blood glucose is easy fluctuated by the intake of food and physical activity [30]. For the treatment of NAFLD, although lifestyle modification, vitamin E, and clinical surgery as main methods are commonly used, there is no effective medicine to prevent the pathological development of it [31].…”

Biopharmaceuticals from microorganisms: from production to purification

“…Similar to chemical drugs, once the patent of a biological product is expired the marketing of biosimilars and generics is possible 79 . These patent expirations, combined with rising healthcare costs and population aging worldwide are paving the way for the development of biosimilars and biobetters, opening new commercial opportunities 80, 81.…”

“…These patent expirations, combined with rising healthcare costs and population aging worldwide are paving the way for the development of biosimilars and biobetters, opening new commercial opportunities 80, 81. Many biosimilars are currently under development and these follow-on products will inevitably play substantial competition and an increasing role in healthcare in upcoming years 79, 82. In Brazil the scenario is modest, but considering the global panel and recent government incentive for the national biopharmaceutical industry development, we expect to see more patents in the near future and also novel opportunities for biosimilars and biobetters.…”

Clinical Outcomes of Patients with Diabetes Who Exhibit Upper-Quartile Insulin Antibody Responses After Treatment with LY2963016 or Lantus® Insulin Glargine

“…Insulin products can elicit the formation of insulin antibodies, often without clinical consequences [8, 9]. However, rare instances exist where the presence of insulin antibodies may have clinically relevant effects on efficacy and safety [9–11].…”

“…However, rare instances exist where the presence of insulin antibodies may have clinically relevant effects on efficacy and safety [9–11]. We have previously shown that the immunogenicity profile of LY IGlar is similar to that of IGlar [7], and that both LY IGlar and IGlar have comparable insulin antibody response (IAR) profiles, with no observed effect on efficacy and safety outcomes [7].…”