Chemical structural formular:
C257H383N65O77S6
Insulin in the blood stream has a half-life of a few minutes. Consequently, the time-action profile of an insulin preparation is determined solely by its absorption characteristics. This process is influenced by several factors (e.g. insulin dose, injection route and site, thickness of subcutaneous fat, type of diabetes). The pharmacokinetics of insulin are therefore affected by significant intra- and inter-individual variation.
Absorption – The product is a mixture of fast-acting insulin and long-acting inulin, so it has the characteristics of rapid and slow absorption at the same time. The maximum plasma concentration of the fast-acting insulin is reached within 1.5-2.5 hours after subcutaneous administration.
Distribution – No profound binding to plasma proteins, except circulating insulin antibodies (if present) has been observed.
Metabolism – It is reported that human insulin can be degraded by insulin protease or insulin-degrading enzymes and possibly protein disulfide isomerase. A number of cleavage (hydrolysis) sites on the human insulin molecule have been proposed, none of the metabolites formed following the cleavage are active.
Elimination - The half-life is determined by the rate of absorption from the subcutaneous tissue. The half-life is therefore a measure of the absorption rather than of the elimination of insulin from plasma (insulin in the blood stream has a half-life of only a few minutes). Trials have indicated a half-life of about 5-10 hours.
The following content is intended to answer your questions only and is not intended to be used for promotional purposes or as a clinical medication guidance.
※ Product Characteristics
● What is the basic information about Similin®30?
The generic name of Similin®30 is Mixed Protamine Recombinant Human Insulin Injection (30R). It consists of two active ingredients: 30% soluble human insulin and 70% insulin human protamine. This medicine is intended for the treatment of people with diabetes and was launched in China in 2021. Similin®30 is a biphasic insulin formulation and is usually administered as a premixed insulin once or twice a day when a rapid onset and prolonged action are required. A regular or additional carbohydrate meal must be taken within 30 minutes of injection. As a biosimilar, Similin®30 closely matches the approved reference medicine (originator) in terms of quality, safety, and efficacy.
● Will Similin®30 cause liver and kidney problems like some oral hypoglycemic drugs?
Similin®30 is not associated with liver or kidney problems. The liver and kidneys are involved in the elimination of the body's own insulin. The introduction of exogenous insulin does not place an additional burden on these organs. In cases of liver or kidney dysfunction, the need for insulin may be reduced due to the reduced breakdown of endogenous insulin. Therefore, people using insulin should continue to monitor their blood glucose levels and adjust their dose if necessary.
● Is injecting Similin®30 injection addictive? Could higher doses lead to dependence?
Similin®30 is not associated with addiction or dependence. Addiction is when an individual develops an intense craving for a substance to obtain psychological or physiological effects, leading to uncontrollable and compulsive use. Unlike addictive substances, Similin®30 is a form of insulin, a natural hormone that is essential for metabolic processes and the maintenance of life. The use of insulin is determined by factors such as blood glucose control and the functioning of the body's β cells. It is not addictive and its necessity is dictated by medical considerations rather than addictive tendencies.
● What are the precautions for the use of Similin®30 in special populations? Are there efficacy and safety data?
Pregnant and breastfeeding women: As insulin doesn't cross the placental barrier, its use in people with diabetes is not restricted during pregnancy (as stated in the prescribing information).
Children: This product has a pharmacokinetic profile in children and adolescent populations that is similar to that in adults, and dosing is determined based on a range of 0.3 to 1.0 U per kilogram of body weight per day (as stated in the prescribing information).
Older people: In the elderly, the main aim of treatment is to relieve symptoms and prevent hypoglycemia as stated in [Dosage] in the prescribing information.
※ Clinical Study
● How does the glucose-lowering efficacy and safety of subcutaneous Similin®30 compare with that of the reference drug, human insulin 30?
A multi-centre Phase 3 clinical trial led by the General Hospital of the People's Liberation Army (PLA) enrolled 510 patients diagnosed with type 2 diabetes mellitus. These participants were randomly assigned to receive either Similin®30 or the original human insulin 30, both administered twice daily over a 24-week period. The primary objective was to compare the efficacy and safety of Similin®30 with an imported reference product for the treatment of diabetes mellitus. The results showed that there were no discernible differences in terms of glucose-lowering efficacy and safety profile between Similin®30 and the imported reference human insulin 30.
※ Clinical Appilication
● Does Similin®️30 require a higher dosage than the original human insulin to achieve equivalent efficacy?
The dosage of Smilin®30 was found to be equivalent to that of the original human insulin. In the Phase 3 clinical trial conducted in China, the results showed no statistically significant difference in dosing between Smilin®30 and the original human insulin 30, with both achieving comparable glycaemic control (p>0.05).
● Can Similin®30 be used in an insulin pump?
Similin®30 cannot be used in insulin pumps.
● What are the advantages of Similin®30?
The use of premixed human insulin has been shown to be more cost-effective than the use of multiple oral medication regimens. In addition, the 30R premixed human insulin protocol has been shown to be more cost-effective than alternative insulin regimens (Hua et al., 2014). Similin®30, with its biphasic approach to glucose control and commendable safety record, offers an economically viable option, positioning it as the preferred choice for primary diabetes management.
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