Stillwater Medical Center, Stillwater, OK, USA.
PharmD Candidate, College of Pharmacy, Southwestern Oklahoma State University, Weatherford, OK, USA.
J Diabetes Sci Technol. 2023 Mar;17(2):490-494. doi: 10.1177/19322968211067511. Epub 2021 Dec 31.
On March 23, 2020, all insulin products were reclassified as biologics instead of drugs under the Biological Price Competition and Innovation (BPCI) Act of 2009. This allows biosimilar insulin products to be manufactured when the patent expires for the reference biologic, sometimes called the originator or brand name product. A biosimilar product may not be substituted for the reference biologic at the pharmacy counter unless the biosimilar undergoes further switch trials to earn the designation as an interchangeable biosimilar. Insulin glargine-yfgn 100 units/mL is the first biosimilar insulin to attain interchangeable status with the reference insulin glargine. In the INSTRIDE 1 and INSTRIDE 2 trials, insulin glargine-yfgn has proven noninferiority regarding blood glucose reduction and adverse effect profile versus reference insulin glargine; even in the INSTRIDE 3 trial in which treatment of diabetes was switched between insulin glargine-yfgn and reference insulin glargine throughout the trial without statistically significant changes to glucose levels or adverse effects. Insulin glargine-yfgn may be substituted at the pharmacy counter without consultation with the prescriber, in accordance with state laws. In suit with other biosimilars, insulin glargine-yfgn's list price is significantly lower than other insulin glargine products. This increases market competition leading to decreases in costs of other insulin glargine products. Many patients who could not previously afford insulin therapy may now have significantly improved access to treatment. Providers will need education to increase awareness of these new biosimilars and interchangeable biosimilar insulin products, cost benefits, and substitution allowances.
2020 年 3 月 23 日，根据 2009 年《生物价格竞争与创新法案》（BPCI 法案），所有胰岛素产品均被重新归类为生物制剂，而非药品。这使得在参照生物制剂的专利到期时，可以生产类似生物制剂的胰岛素，有时也称为原创药或品牌药。在药房柜台，除非类似生物制剂进行进一步的转换试验以获得可互换类似生物制剂的指定，否则不能用类似生物制剂替代参照生物制剂。胰岛素甘精育亨宾 100 单位/毫升是第一种获得可互换地位的类似胰岛素的参照胰岛素甘精。在 INSTRIDE 1 和 INSTRIDE 2 试验中，与参照胰岛素甘精相比，胰岛素甘精育亨宾在降低血糖和不良影响方面表现出非劣效性；即使在 INSTRIDE 3 试验中，在整个试验期间，糖尿病的治疗在胰岛素甘精育亨宾和参照胰岛素甘精之间转换，而血糖水平或不良影响没有统计学上的显著变化。根据州法律，胰岛素甘精育亨宾可以在药房柜台无需咨询处方医生而进行替代。与其他类似生物制剂一样，胰岛素甘精育亨宾的定价显著低于其他胰岛素甘精产品。这增加了市场竞争，导致其他胰岛素甘精产品的成本降低。许多以前无法负担胰岛素治疗的患者现在可能有更好的治疗机会。提供者需要接受教育，以提高对这些新的类似生物制剂和可互换类似生物制剂胰岛素产品、成本效益以及替代许可的认识。
