Production costs and potential prices for biosimilars of human insulin and insulin analogues.
Production costs and potential prices for biosimilars of human insulin and insulin analogues.
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DOI：
10.1136/bmjgh-2018-000850
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发表时间：
2018
影响因子：
8.1
通讯作者：
Hill A
中科院分区：
文献类型：
--
作者：
Gotham D;Barber MJ;Hill A
胰岛素的高价格对糖尿病患者的治疗构成了障碍，据估计，在1亿 需要胰岛素的患者中，有50%缺乏可靠的途径。随着胰岛素类似物在全球范围内取代常规人胰岛素(RHI)，其相对价格将变得越来越重要。三家始创公司控制着全球96%的胰岛素市场，几乎没有生物相似的胰岛素可用。我们估计了如果许多生物相似的制造商进入胰岛素市场可能实现的降价。印度出口的活性药物成分(原料药)的价格数据是从一个在线海关数据库中检索的。他们联系了胰岛素制造商，以获得报价。在无法确定市场原料药价格的情况下，价格是根据制造工艺与已有价格的原料药的相似性进行比较而估算的。潜在的生物相似价格是通过添加辅料成本、配方、运输、开发和监管成本以及利润率来估计的。RHI和胰岛素类似物的制造工艺相似。原料药的价格为：RHI为24 750美元/公斤，甘精胰岛素为68 757美元/公斤，其他类似物估计为100 000美元/公斤。估计生物相似价格为：RHI每位患者每年48-71美元，中性鱼精蛋白Hagedorn(NPH)胰岛素49-72美元，类似物78-133美元(除地替米尔外：283-365美元)。使用生物相似的RHI和胰岛素NPH治疗每年可花费≤72美元，使用胰岛素类似物≤每年可花费133美元。估计的生物相似价格明显低于胰岛素类似物的当前价格。估计价格的广泛供应可能会在全球范围内节省大量资金。
High prices for insulin pose a barrier to treatment for people living with diabetes, with an estimated 50% of 100 million patients needing insulin lacking reliable access. As insulin analogues replace regular human insulin (RHI) globally, their relative prices will become increasingly important. Three originator companies control 96% of the global insulin market, and few biosimilar insulins are available. We estimated the price reductions that could be achieved if numerous biosimilar manufacturers entered the insulin market. Data on the price of active pharmaceutical ingredient (API) exported from India were retrieved from an online customs database. Manufacturers of insulins were contacted for price quotes. Where market API prices could not be identified, prices were estimated based on comparison of similarity, in terms of manufacturing process, with APIs for which prices were available. Potential biosimilar prices were estimated by adding costs of excipients, formulation, transport, development and regulatory costs, and a profit margin. The manufacturing processes for RHI and insulin analogues are similar. API prices were US$24 750/kg for RHI, US$68 757/kg for insulin glargine and an estimated US$100 000/kg for other analogues. Estimated biosimilar prices were US$48–71 per patient per year for RHI, US$49–72 for neutral protamine Hagedorn (NPH) insulin and US$78–133 for analogues (except detemir: US$283–365). Treatment with biosimilar RHI and insulin NPH could cost ≤US$72 per year and with insulin analogues ≤US$133 per year. Estimated biosimilar prices were markedly lower than the current prices for insulin analogues. Widespread availability at estimated prices may allow substantial savings globally.
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影响因子：
5.5
作者：
Clendinen, Chaevia;Zhang, Yapei;Light, Donald W.
通讯作者：
Light, Donald W.
影响因子：
3.8
作者：
Laustsen, Andreas H.;Johansen, Kristoffer H.;Andersen, Mikael R.
通讯作者：
Andersen, Mikael R.
影响因子：
--
作者：
Sandow, Juergen;Landgraf, Wolfgang;Seipke, Gerhard
通讯作者：
Seipke, Gerhard
影响因子：
16.2
作者：
Beran, David;Hirsch, Irl B.;Yudkin, John S.
通讯作者：
Yudkin, John S.
影响因子：
5.2
作者：
Gotham, Dzintars;Fortunak, Joseph;Hill, Andrew
通讯作者：
Hill, Andrew