Introduction

Biosimilars or ‘follow-on-biologics’ are biologic products similar to a reference biologic and for which there are no clinically meaningful differences with respect to purity, safety and potency. Once patents expire for biologic medicines, opportunity opens for cheaper biosimilars to enter the market, as seen for small molecule generics. Since their inception, biosimilars have garnered popularity and acceptance in the medical armamentarium. This is attributed to reduced healthcare costs – both for the patients and the payers.

由于无法保护世界上一些最高价值的产品：Humira，Enbrel和Remicade的保护丧失，因此在过去的10年中，排他性事件的生物损失在过去的10年中已增长。据推测，由于生物学发射的数量大量，这种趋势将在未来10年中继续进行。保持这一点，IQVIA模拟计划者专利（APOP）tool 2021 launch has incorporated biosimilars for the first time to its extensive pool of generics across 8 countries to support the generation of justifiable forecasts for branded products (small molecule and biologic) and their generic competitors following patent expiry. The below exhibit shows the coverage of 94 Biosimilars across 8 major markets in APOP.

该工具提供了一个历史LOE事件的数据库，该数据库符合可能影响通用/生物仿制药影响的27个关键标准。这些标准包括基本信息，例如治疗类别，原始公司或配方，以对销售和数量侵蚀，价格差异或促销支出进行更详细的分析 - 该工具涵盖了所有内容。这些标准可用于确定未来LOE事件的类似物，因此预测可能对原始品牌和通用/生物仿制药竞争对手产生影响。

The APOP interface thus enables the user to enrich their analysis and forecast future LOE events by selecting any combination of the key criteria to identify suitable historical analogues. For example, using the APOP database it was observed that on average, historical biosimilars had been launched at a price differential of 20-24% in France.

Biosimilars’ Market Overview

全球生物仿制药市场目前显示出两位数的增长，预计未来几年将保持相似的吸收水平。这将由慢性疾病的发生率上升和生物仿制药的成本效益驱动，尤其是在COVID-19-19大流行之后，更严格的成本控制措施很可能。

This trend is clearly seen across the 8 countries covered by APOP - the below figures portray the rising trend of biosimilars since 2015.

如果我们在2019年查看每个国家的生物仿制药的份额，那么很明显，在EU5市场中，生物仿制药的吸收更加先进：

在治疗水平上 - 生物仿制化产业分为胰岛素，单克隆抗体，重组人类生长激素，粒细胞菌落刺激因子，干扰素，erythropoietin，Etanercept，依那诺酯，卵泡素，卵泡素，胰糖蛋白，胰糖蛋白，结石蛋白，teriparatiide和Enoxaparins和Enoxaparin sodium sodium。在这些细分市场中，单克隆抗体由于癌症的发生率增加和产品发布或批准数量而倾向于捕获更大的市场份额。下图显示了自2015年以来八个APOP国家单克隆抗体的销售增长。

The Analogue tool can support a wide range of such analyses. The data covered in APOP is at brand, molecule and generic level and includes several measures such as: Sales in dollars (LCD), Standard Units (SU), Kilograms (KG), Market share at molecule and ATC4 level and Price per standard unit (SHP). By combining these measures with the selection criteria, the user can perform a range of different analyses and build a deeper understanding of the generic and biosimilar markets.

Conclusion

预计生物仿制药将继续增长其市场份额，并在专利到期和监管改进的帮助下，这将使市场更容易，更快。目睹这一趋势的制药公司现已开始利用生物仿制药的机会。

With a rich pool of 3769 historical LOE events including biosimilars, Analogue Planner Off-Patent thus provides potential benchmarks for forecasting brand erosion, generic/biosimilar uptake and enables the user to leverage these trends to their advantage.