生物仿制药利用不足本身并不预示着生物制剂市场的崩溃

F. LaMountain, Molly T Beinfeld, William Wong, Eunice Kim, James D Chambers
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摘要

生物仿制药具有节约成本和扩大生物制品使用范围的潜力,但人们对生物仿制药的吸收率存在担忧。我们评估了生物仿制药与原研药定价、覆盖范围和市场份额之间的关系,并将四个案例研究分为两类:(1) 唯一优先覆盖战略(即目标是原研药产品优先;生物仿制药非优先),定义为原研药产品的 ASP 锐减(到 2022 年引入生物仿制药竞争后,净价格下降至少 50%);(2) 非唯一优先覆盖战略(即目标是原研药产品与生物仿制药同时优先),定义为原研药产品的 ASP 锐减(到 2022 年引入生物仿制药竞争后,净价格下降至少 50%)、(2) 非独家优先覆盖战略(即,旨在使原研产品与生物类似药产品同时获得优先覆盖),定义为原研产品的 ASP 降幅适中(净价格至少没有下降到生物类似药竞争前价值的 50%)。我们发现,与采用非独家优先覆盖策略的原研药相比,采用独家优先覆盖策略的原研药能保持处方集优先权和市场份额。无论采用哪种策略,所有四个产品系列(原研药和生物仿制药)的市场加权平均售价在生物仿制药推出后的几年中都出现了显著下降,这表明仅凭生物仿制药的吸收量可能无法全面衡量生物仿制药市场是否促进了竞争并降低了价格。
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Biosimilar underutilization alone does not foretell a broken biologics market
Biosimilars offer the potential for cost savings and expanded access to biologic products, however, there are concerns regarding the rate of biosimilar uptake. We assessed the relationship between biosimilar and originator pricing, coverage, and market share by describing four case studies that fall into two categories: (1) sole preferred coverage strategy (i.e., aim is to have originator product preferred; biosimilar(s) non-preferred), defined as steep ASP reductions for originator products (decline in net prices by at least 50% following the introduction of biosimilar competition by 2022) and (2) non-sole preferred coverage strategy (i.e., aim is to have originator product preferred alongside biosimilar products), defined as moderate ASP reductions for originator products with (net prices did not decline by at least 50% of its pre-biosimilar competition value). We found that originators with sole preferred coverage strategies maintained formulary preference and market share relative to originators with non-sole preferred coverage strategies. Regardless of strategy, the market-weighted ASP for all four product families (originator and biosimilars) declined significantly in the years following the introduction of biosimilars, suggesting that biosimilar uptake alone may not be a complete measure of whether the biosimilar market is facilitating competition and lowering prices.
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