PDF(Pubmed)
Abstract：
Achieving and maintaining optimal glycemic targets is the fundamental goal of the management of diabetes. However, failure of oral antidiabetic drugs (OADs) to sustain the targeted glycemic levels in individuals with progressing disease often requires initiation of insulin therapy. This article consolidates the expert opinions of 377 doctors who participated in 34 advisory board meetings held digitally (n=23) and in person (n=11) across India. The present report underscores the need for readily available alternatives, such as biosimilar insulins, in the Indian healthcare market to make insulin accessible to every patient with diabetes. The introduction of biosimilar insulins in the Indian healthcare market is the key to making insulin accessible to every patient with diabetes. Biosimilars are biologic products that closely resemble reference/originator biologics and demonstrate no clinically meaningful differences in safety and effectiveness. The concept of interchangeability serves as a pivotal differentiator for biosimilars, underlining their reliability and safety, and plays a significant role in their broader acceptance and integration into healthcare systems. The \'interchangeability\' designation by the United States Food and Drug Administration (USFDA) elevates the biosimilar concept, promoting faster and broader adoption of insulin biosimilars, especially benefiting patients prone to non-adherence to insulin therapy. Healthcare providers are encouraged to consider the option of initiating or transitioning to biosimilar insulin glargine to address the insulin accessibility challenges.
摘要：
实现和维持最佳血糖目标是糖尿病管理的基本目标。然而,口服抗糖尿病药物(OAD)未能维持疾病进展患者的目标血糖水平,通常需要开始胰岛素治疗.本文合并了377名医生的专家意见，他们参加了印度各地以数字方式（n=23）和亲自（n=11）举行的34次咨询委员会会议。本报告强调需要现成的替代品，如生物类似胰岛素，在印度医疗保健市场，使每个糖尿病患者都能获得胰岛素。在印度医疗保健市场引入生物仿制药胰岛素是使每个糖尿病患者都能获得胰岛素的关键。生物仿制药是与参考/鼻祖生物制剂非常相似的生物产品，在安全性和有效性方面没有临床意义的差异。互换性的概念是生物仿制药的关键区别，强调其可靠性和安全性，在更广泛的接受和整合到医疗保健系统中发挥着重要作用。美国食品和药物管理局（USFDA）的“互换性”名称提升了生物仿制药的概念，促进更快、更广泛地采用胰岛素生物仿制药，尤其有利于容易不坚持胰岛素治疗的患者。鼓励医疗保健提供者考虑开始或过渡到甘精胰岛素生物仿制药的选择，以解决胰岛素可及性挑战。
