Financial evaluation of value-creating biosimilar development candidates: a business case study of low-, medium- and high-sales biosimilars

Selection of a biosimilar development candidate requires detailed and careful analysis to ensure value creation. We applied the net present value (NPV) model for financial evaluation of biosimilar development candidates for the global market. Biosimilar development candidates from three categories were identified based on the global sales of their respective original biological products (OBPs): >$1 and ≤$4 billion, >$4 and ≤$7 billion and >$7 and ≤$10 billion. The standard NPV and risk-adjusted NPV (rNPV) were calculated under the base-case and various scenarios related to development costs, sales, selling, general and administrative expense, cost of goods sold, and discount rates. A biosimilar to an OBP with sales of $1.6 billion has some financial risk. Biosimilars to OBPs with sales of $5.5 billion and $9.4 billion have very less financial risk under the base-case scenario of analysis. Sales of an OBP had impact on the financial valuation and attractiveness of a biosimilar. Sensitivity of rNPV to different parameters varied for three biosimilars. Discount rates, sales and development costs were important parameters affecting financial valuation of biosimilars. Biosimilar development candidate selection requires a thorough financial evaluation considering product-, company- and market-specific aspects.

生物类似药（biosimilar）开发候选品种的遴选需开展详尽细致的分析，以确保实现价值创造。我们针对全球市场的生物类似药开发候选品种，采用净现值（net present value, NPV）模型开展财务评估。基于各原研生物制品（original biological products, OBPs）的全球销售额，将候选品种划分为三类：销售额大于10亿美元且不超过40亿美元、大于40亿美元且不超过70亿美元，以及大于70亿美元且不超过100亿美元。我们在基准情景及与开发成本、销售额、销售、一般及行政费用、销货成本以及折现率相关的多种情景下，计算了标准净现值与风险调整后净现值（risk-adjusted NPV, rNPV）。一款对应销售额为16亿美元原研生物制品的生物类似药，存在一定财务风险。对应销售额55亿美元与94亿美元原研生物制品的生物类似药，在基准分析情景下的财务风险极低。原研生物制品的销售额会对生物类似药的财务估值与投资吸引力产生影响。三种生物类似药的风险调整后净现值对不同参数的敏感性存在差异。折现率、销售额与开发成本是影响生物类似药财务估值的关键参数。生物类似药开发候选品种的遴选，需结合产品、企业及市场的特定维度，开展全面深入的财务评估。