Bevacizumab biosimilar (mAbxience)

点个关注吧~ 近年来，生物制剂在肿瘤治疗领域的应用日益广泛，但其高昂的采购成本给各国医疗系统带来了持续增长的财政压力。生物类似药的问世为这一困境提供了破解之道——在质量、安全性和疗效与原研药高度可比的前提下，价格显著更低。然而，来自中低收入国家的真实世界经济学证据仍然稀缺。近日，发表于 Cost Effectiveness and Resource Allocation 的一项研究填补了这一空白，基于厄瓜多尔一家三级公立医院2019年至2026年的真实世界药房数据，评估了贝伐珠单抗生物类似药（MB02）采用所带来的成本规避效应。 核心研究结果 七年节省350万美元，生物类似药占比达91.9% 表1 贝伐珠单抗使用量（2019-2026） 表2 贝伐珠单抗年度支出（2019-2026） 表3 贝伐珠单抗两种产品每瓶采购成本对比 表4 贝伐珠单抗成本规避估算 经济层面：研究期间共 dispensed 6,431瓶贝伐珠单抗，其中生物类似药占比高达91.9%（5,912 瓶）。在“仅使用原研药”的反事实情景下，假设支出为5,462,097.60美元，而实际生物类似药支出仅为 1,963,376.00美元，总成本规避达3,498,721.60美元（64.1%）。从2023年起，该院所有贝伐珠单抗使用已完全切换为生物类似药，年度支出在用量持续增长的情况下保持相对稳定。 成本差异对比：生物类似药100 mg规格采购成本为178美元/瓶，较原研药（353.70美元）低 49.7%；400 mg规格为438美元/瓶，较原研药（1,315.75美元）低66.7%。 敏感性与不确定性分析：结果稳健可靠 图1 贝伐珠单抗生物类似药应用相关的成本规避估计值的自助法分布图 Bootstrap重抽样（1,000次迭代）显示，成本规避均值估计为 3,497,843美元，95%置信区间为3,443,896 – 3,548,402 美元，与确定性估算高度一致。  表5 贝伐珠单抗单因素确定性敏感性分析（±20%原研药价格变动） 单因素确定性敏感性分析：在原研药价格 ±20% 变动的极端情景下，成本规避金额介于2,406,302美元至 4,591,141 美元之间，结论依然稳健。 研究意义与实践启示 填补中低收入国家证据空白 既往生物类似药经济学研究多集中于高收入国家，本研究首次从拉丁美洲中收入国家三级公立医院的视角，提供了基于真实世界7年数据的本土化证据。厄瓜多尔于2019年通过Ministerial Agreement No. 00385-2019建立了生物药注册途径，但本地化经济学数据的长期缺乏制约了循证采购决策。本研究直接回应了这一政策需求。 临床与经济的双重获益 生物类似药的采用不仅实现了64.1%的成本规避，还在治疗用量持续增长的情况下维持了年度支出稳定。在资源有限的医疗系统中，这意味着节省的资金可重新配置到其他优先医疗领域。 卫生政策参考 本研究为其他中低收入国家评估生物类似药的经济价值提供了方法学范本，提示清晰的监管框架、透明的采购流程和本地化真实世界证据的有机结合，是推动生物类似药有效采用的关键要素。 研究局限性与展望 本研究疗效数据基于III期临床试验及监管可比性评估的等效性假设，未在本地队列中验证临床结局；分析仅纳入直接采购成本，未包含税收、分销、损耗等费用；采用机构视角，未纳入间接成本和社会影响；不确定性分析仅使用Bootstrap重抽样，未进行概率敏感性分析。未来研究需整合患者层面数据、拓展社会视角，并开展多中心合作以增强结论的普适性。 贝伐珠单抗生物类似药在厄瓜多尔的成功实践表明，在合理监管与循证采购的支持下，生物类似药可作为资源有限医疗系统中优化药品支出、提升肿瘤服务可持续性的有效策略。 END 【期刊速览：文章发表期刊】 《Cost Effectiveness and Resource Allocation》是这是一本专注于卫生经济学领域的期刊，主要发表关于成本效果分析、经济评估以及国家或国际层面资源配置政策分析的文章。 题目：Real-world cost avoidance associated with bevacizumab biosimilar adoption in a tertiary public hospital in Ecuador: a cost-minimization and budget impact analysis 参考文献：Rodríguez, S., Arias, C., Aynaguano, M.d.C. et al. Real-world cost avoidance associated with bevacizumab biosimilar adoption in a tertiary public hospital in Ecuador: a cost-minimization and budget impact analysis. Cost Eff Resour Alloc (2026). 撰稿人信息： 段阳勇 内蒙古医科大学2025级临床药学专硕研究生 龙行东海风云阔，马放南山岁月闲； 人运随缘心自定，万事从容皆坦然。 往期推荐 aiResearch 【组会推文第32期】｜心衰风险能“算”出来？这项研究用机器学习给老年糖高血压患者画了张“风险地图” aiResearch 【组会推文第31期】｜5.6万例数据验证：常规抽血+XGBoost，让69种心血管疾病无所遁形 aiResearch 【组会推文第30期】｜女性骨质疏松早期筛查新工具：OsteoSC-M3模型研究解读 撰文|段阳勇 编辑|赵优美 武晓然 审校|林国华 核发|赵龙山

Promotional materials for Lucemyra and Alymsys have come under the OPDP's scrutiny. Amneal and BioCorRx have earned the ire of the FDA’s Office of Prescription Drug Promotion (OPDP), with both being hit by accusations of violating the agency’s drug marketing rules. The two pharmas received separate untitled letters from the U.S regulator detailing the offenses in late March, with both published on the FDA’s site on April 9. The letter (PDF) to BioCorRx centers on the consumer webpage for the company’s Lucemyra (lofexidine), a non-opioid prescription medicine used in adults to help with the symptoms of opioid withdrawal.The FDA said that the drug’s “webpage is false or misleading [and] misbrands Lucemyra.”  The misbranding comes from the site’s assertion that Lucemyra is “the only FDA-approved, non-opioid medicine proven to help with symptoms of opioid withdrawal.”The FDA points out that it has in fact green lit other lofexidine products in the same indication. The regulator also took umbrage with the company’s decision to highlight 2020 guidance from the American Society of Addiction Medicine in large bolded font. The guidance states that lofexidine “should therefore be the preferred choice for withdrawal management in an outpatient setting, where monitoring of blood pressure and management of hypotension is more difficult.” But the FDA points out that in contrast, the med’s full risk information is “only presented separately under the header, ‘Click to see full Important Safety Information & Prescribing Information,’ with lesser prominence.”The OPDP noted in its letter that: “The overall effect of this presentation undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Lucemyra.”The other letter (PDF) was for Amneal and its drug Alymsys (bevacizumab-maly), a biosimilar to Roche’s oncology drug Avastin. Specifically, the OPDP said a direct-to-consumer patient brochure was “misleading” as it didn’t show Alymsys’s full FDA-approved indications. “The presentations of the indications for Alymsys omit specific patient populations as well as its specific administration in combination with other chemotherapies,” the OPDP found. The letter also details the brochure’s failure to “disclose material risk information regarding the serious risks associated with Alymsys,” which includes cause fetal harm when administered to pregnant women, as well as minimizing other risk factors. This includes an assertion that all patients can expect that their side effects will resolve over time, “when this is not the case,” the FDA said. Both companies were given 15 days on receipt of their letters to respond and come up with a plan to deal with the promotional violations.