Secukinumab

导语：曾经年销 220 亿美元的药王 Humira 正经历 “退位潮”。随着专利保护到期，生物类似药的价格战与新疗法的崛起正加速改写免疫治疗版图。当医生开始用 “adalimumab” 通用名处方，当 CVS 将原研药移出报销目录，这场药王退位战已演变为一场关乎行业规则的深度变革。一、专利到期后的市场震荡：从 “药王” 到 “平民药” Humira（阿达木单抗）曾连续多年稳坐全球药王宝座，2021 年销售额突破 220 亿美元。但 2023 年专利到期后，其市场地位迅速崩塌： 销售额腰斩：2024 年全球销售额降至 98 亿美元，美国市场份额从 80% 跌至 62%。 生物类似药井喷：12 款 Humira 生物类似药涌入市场，Amgen 的 Amjevita、Sandoz 的 Hyrimoz 等通过低价策略抢占份额，其中 Amjevita 2024 年销售额同比激增 22% 至 7.61 亿美元。 支付方倒逼转型：CVS Caremark 将 Humira 移出报销目录后，Hyrimoz 处方量暴增，其 2024 年价格仅为原研药的 20%。二、生物类似药的价格战与渠道博弈 生物类似药的竞争核心在于价格与渠道： 价格屠夫策略：Sandoz 与 CVS 合作推出私有品牌 Hyrimoz，定价仅为原研药的 20%；辉瑞 Abrilada 以 539 美元 / 两剂成为市场最低价。 处方权争夺：医生开始使用通用名 “adalimumab” 开具处方，由保险公司决定具体品牌。风湿病学家处方中，生物类似药占比从 2023 年的 3% 升至 2024 年的 10%。 渠道分层：诺华 Cosentyx、强生 Stelara 等新疗法通过更高疗效（如银屑病皮肤清除率达 90%）吸引高净值患者，而生物类似药主攻价格敏感型市场。三、专科医生的处方革命：从 “忠诚” 到 “理性” 不同专科医生对生物类似药的接受度差异显著： 风湿病学：生物类似药占比已达 38%，Hyrimoz 以 33% 的份额领跑，预计 2025 年原研药份额将降至 12%。 皮肤病学：生物类似药占比仅 4%，因患者更倾向选择 J&J 的 Stelara（IL-12/23 抑制剂）等新一代药物，其皮肤清除率比 Humira 高 30%。 胃肠病学：生物类似药占比 6%，但新指南推荐优先使用 Takeda 的 Entyvio（α4β7 整合素抑制剂）等靶向疗法。 “医生更关注疗效与患者体验，而非品牌忠诚度。”Spherix Global Insights 专家 Lynn Price 指出，“生物类似药的成功源于支付方压力，而非临床优势。”四、新疗法的逆袭：从 “me-too” 到 “best-in-class” 新疗法的崛起加速了 Humira 的衰落： 机制创新：IL-17 抑制剂（Cosentyx）、IL-23 抑制剂（Skyrizi）等精准靶向疗法，将银屑病治疗有效率从 60% 提升至 85%。 口服药冲击：辉瑞的 JAK 抑制剂 Xeljanz（2024 年销售额 18 亿美元）以每日一片的便捷性分流轻中度患者。 联合疗法趋势：礼来的 Taltz（IL-17A 抑制剂）与甲氨蝶呤联用，使类风湿关节炎患者达标率提升 40%。五、行业启示：药王退位背后的生态重构 Humira 的衰落揭示出三大行业趋势： 专利悬崖效应加剧：未来 5 年，全球将有超 2000 亿美元专利药到期，生物类似药市场规模将突破 1500 亿美元。 支付方话语权增强：美国医保通过 “参考定价” 等策略，推动生物类似药市场渗透率从 10% 升至 30%。 创新药定价逻辑生变：新疗法需通过 “疗效溢价” 而非 “市场独占” 维持高价，如诺华 Kisqali 凭借 OS 延长 4 个月定价 15 万美元 / 年。六、未来展望：生物类似药与创新药的共生时代 尽管生物类似药短期内抢占市场，但长期来看： 生物类似药面临同质化竞争：12 款阿达木单抗生物类似药将陷入价格战，预计 2026 年平均价格将降至原研药的 15%。 创新药聚焦差异化：基因泰克的 Tecentriq（PD-L1 抑制剂）、渤健的 Zeposia（S1P 调节剂）等通过 “多适应症布局 + 精准医疗” 开辟新赛道。 行业整合加速：CMO 企业如 Catalent 通过收购扩展生物类似药产能，而 Biogen 等药企则剥离传统管线，聚焦基因治疗等高壁垒领域。 七、结语Humira 的退位不是终点，而是免疫治疗新时代的起点。当生物类似药将单抗价格拉入 “千元时代”，当创新疗法重新定义疗效标准，这场药王黄昏战正深刻改变全球医药产业的价值逻辑。而患者，终将成为这场变革最大的受益者 —— 在疗效与价格之间，他们第一次拥有了真正的选择权。 参考来源：https://www.biospace.com/business/humira-biosimilars-gain-ground-as-doctors-adjust-and-new-therapies-rise 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！ 请注明：姓名+研究方向！ 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

The flurry of immunology biotech launches continues. Boston-based Hillstar Bio on Tuesday became the latest immunology startup launch, unveiling a $67 million Series A round funded by Droia Ventures, Frazier Life Sciences, Novo Holdings and LifeArc Ventures. The biologics developer has been in the works since 2023, CEO Robert Mabry told Endpoints News . Mabry joined Hillstar in recent months after departing his chief scientific officer post at RNA medicines outfit Orna Therapeutics . “It’s just such a fantastic time for biologics right now. You’re seeing just a renaissance. All the technology is coming to fruition,” Mabry said. With the Series A, Hillstar expects to get into the clinic next year with its first biologic. The startup will begin in axial spondyloarthritis, or axSpA. The inflammatory condition leads to lower back pain, causing arthritis in the spine and other joints and organs. Approved medicines for the condition include Novartis’ Cosentyx, UCB’s Bimzelx and AbbVie’s Rinvoq . Others, like Acelyrin, once had ambitions in the space. Hillstar’s HSB-101 biologic targets TRBV9 + T cells. The goal is to invoke an “immune reset,” Mabry said. Beyond its lead asset, Hillstar could go into cold agglutinin disease, or CAD, according to a job posting for the company. In the rare condition, a patient’s immune system prematurely kills red blood cells. Sanofi sold Enjaymo, its approved drug for the condition, to Recordati for $825 million in October. “It’s still an area that we’re exploring,” Mabry said of CAD. “What we’ve been able to generate is a proprietary dataset using patient samples in that area, so we’re very excited about that as one of many different autoimmune diseases that we can go after.” Leading the biotech’s development is former Boston Pharmaceuticals clinical development SVP Mitchell Keegan. Hillstar’s chief operating officer is Lauren Mifflin, a principal of company creation at one of the startup’s key investors, Frazier Life Sciences. Hillstar’s board includes Mabry, Ingram, Novo Holdings senior partner Kenneth Harrison, Frazier General Partner Dan Estes, Droia Managing Partner Luc Dochez and Droia Partner Matthias Van Woensel. Mabry emphasized that the startup is an asset-focused company with drugs near the clinic — a profile investors have favored over the last few years of a moribund biotech sector. “We’re an asset company, a pipeline company — we’re not a platform technology company,” Mabry said. “That really changes the way you can run a biotech company. It changes the way you use the capital.” Along with the investment funds, another key Hillstar backer is Hummingbird Bioscience, a Singapore-based biotech that originated about a decade ago and that has antibody and antibody-drug conjugate platforms. Earlier this month, Frazier and Novo Holdings backed an ADC spinout from Hummingbird called Callio Therapeutics . “They’ve been a great shareholder for us and so being able to leverage them as part of our development, but also gaining access to other technologies that provide a lot of insight into development, that’s been a great partnership for us,” Mabry said of Hummingbird.