A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis

This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK, PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.

开始日期2020-11-26

申办/合作机构

Samsung Bioepis Co., Ltd.

NCT04621318

/ Completed临床1期

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (SB16, EU Sourced Prolia®, and US Sourced Prolia®) in Healthy Male Subjects

This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.

开始日期2020-10-19

申办/合作机构

Samsung Bioepis Co., Ltd.

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项与地舒单抗生物类似药 (Samsung Bioepis) 相关的文献（医药）

2025-12-01·ANTONIE VAN LEEUWENHOEK INTERNATIONAL JOURNAL OF GENERAL AND MOLECULAR MICROBIOLOGY

Multifunctional lactic acid bacteria isolated from traditional Makdous

Article

作者: Koçan, Deniz ; Aydın, Furkan ; Kahve, Halil İbrahim

This study aimed to isolate and identify lactic acid bacteria from traditionally fermented Makdous, with a focus on selecting strains suitable for safe and functional fermentation. A total of 33 isolates were identified by 16S rRNA gene sequencing as Levilactobacillus brevis (n = 29) and Lactiplantibacillus plantarum (n = 4). Technological characterisation, comprising acidification, exopolysaccharide production, and tolerance to salt, acid, and acetic acid, was followed by multivariate analysis, which identified five promising strains: Lev. brevis SB4 and Lp. plantarum SB6, SB12, SB14, and SB16. These strains, alongside the reference Lacticaseibacillus rhamnosus GG, were further evaluated for in vitro probiotic properties. Among them, Lev. brevis SB4 and Lp. plantarum SB14 stood out due to high autoaggregation, surface hydrophobicity, antioxidant activity, and antimicrobial effects. Notably, Lp. plantarum SB14 showed the highest radical scavenging activity, while SB4 demonstrated potent inhibition against Listeria monocytogenes ATCC 13932 and Staphylococcus aureus ATCC 43300. These findings suggest that SB4 and SB14 are strong candidates as multifunctional starters to enhance the safety, quality, and health-promoting potential of fermented vegetable products and other functional food applications.

2025-05-19·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12

Article

作者: Urboniene, Audrone ; Supronik, Jerzy ; Mordaka, Robert ; Rowińska-Osuch, Anna ; Dokoupilova, Eva ; Eastell, Richard ; Langdahl, Bente ; Rosa, Jan ; Plebanski, Rafal ; Rho, Young Hee ; Mydlak, Andrzej ; Chung, Yoon-Sok ; Baek, Ki-Hyun ; Ban, Jisuk ; Ahn, Sohui ; Czerwinski, Edward

Abstract:

Context:

SB16 is a proposed biosimilar to reference denosumab (DEN; brand name: Prolia).

Objective:

This phase 3 randomized, double-blind, multicenter study evaluated the biosimilarity of SB16 to DEN in women with postmenopausal osteoporosis (NCT04664959).

Design:

The study included 457 postmenopausal osteoporosis patients who had a lumbar spine or total hip T-score between −2.5 and −4. Patients were randomized in a 1:1 ratio to receive either 60 mg of SB16 or DEN subcutaneously at month 0 and month 6. At month 12, patients were rerandomized to continue with the assigned treatment or switch from DEN to SB16 up to month 18. This report includes results up to month 12.

Methods:

The primary endpoint was the percent change from baseline in lumbar spine bone mineral density (BMD) at month 12. Secondary endpoints including the percent change from baseline in BMD of the lumbar spine (except for month 12), total hip, and femoral neck; pharmacokinetic, pharmacodynamic (serum C-telopeptide of type I collagen, and procollagen type I N-terminal propeptide), safety, and immunogenicity profiles were measured up to month 12.

Results:

The least-squares mean differences in percent change from baseline in lumbar spine BMD at month 12 were 0.33% (90% CI, −0.25 to 0.91) in the full analysis set and 0.39% (95% CI, −0.36 to 1.13) in the per-protocol set; both within the predefined equivalence margin. The secondary endpoints were comparable between the 2 treatment groups.

Conclusion:

The reported efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.

2025-03-01·BONE

SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial

Article

作者: Urboniene, Audrone ; Supronik, Jerzy ; Mordaka, Robert ; Baek, Ki-Hyun ; Eastell, Richard ; Dokoupilova, Eva ; Langdahl, Bente ; Rosa, Jan ; Plebanski, Rafal ; Rho, Young Hee ; Ahn, Sohui ; Mydlak, Andrzej ; Sapula, Rafal ; Chung, Yoon-Sok ; Rowińska-Osuch, Anna ; Ban, Jisuk ; Czerwinski, Edward

PURPOSE:

This study evaluated the efficacy, safety, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of SB16 versus reference denosumab (DEN) up to 18 months in postmenopausal osteoporosis (PMO) patients, and assessed outcomes after switching from DEN to SB16 compared to those who continued with DEN or SB16.

METHODS:

457 PMO patients were initially randomized, with 407 re-randomized at Month 12 to either continue DEN (DEN+DEN), switch to SB16 (DEN+SB16), or continue SB16 (SB16 + SB16) through Month 18. Efficacy was assessed by the percent change from baseline in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck. Safety, PD, PK, and immunogenicity were evaluated throughout the study period.

RESULTS:

Mean percent changes from baseline in lumbar spine, total hip, and femoral neck BMD at Month 18 were comparable across treatment groups, indicating comparable efficacy between SB16 and DEN. The mean percent change in lumbar spine BMD was 6.8 % (SB16 + SB16), 6.2 % (DEN+SB16), and 6.8 % (DEN+DEN). Total hip BMD increased by 4.4 %, 3.5 %, and 4.0 %, and femoral neck BMD by 3.4 %, 3.1 %, and 2.7 % for SB16 + SB16, DEN+SB16, and DEN+DEN, respectively. Safety profiles were similar among groups, with no new safety concerns identified after switching. Only one patient in the DEN+SB16 group developed non-neutralizing anti-drug antibodies by Month 18, indicating a low immunogenicity risk for SB16.

CONCLUSION:

Switching from DEN to SB16 demonstrated comparable efficacy, safety, PD, PK, and immunogenicity in PMO patients relative to those who continued DEN. SB16 was well tolerated over 18 months, demonstrating comparable outcomes to DEN.

项与地舒单抗生物类似药 (Samsung Bioepis) 相关的新闻（医药）

2025-12-01

·Business Wire

Samsung Bioepis Announces Launch of Denosumab Biosimilars, OBODENCE™ and XBRYK™, in Europe

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced the launch of OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. The products will be commercially available in Europe in December 2025 and January 2026, respectively. With our proven track records, we’re confident that OBODENCE and XBRYK will deliver meaningful impact on patients and their communities. “We are very thrilled to launch OBODENCE and XBRYK through our direct sales efforts. Osteoporosis remains a major challenge in Europe due to limited treatment options and affordability challenges. And bone-related events resulting from bone metastases significantly impact a patient's quality of life, leading to death if not treated fast enough. Our biosimilars aim to improve access, enable timely care, and ease the financial burden on healthcare systems.”, said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial Division at Samsung Bioepis. “With our proven track records, we’re confident that OBODENCE and XBRYK will deliver meaningful impact on patients and their communities.” OBODENCE, referencing Prolia, has been approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. XBRYK, referencing Xgeva, has been approved for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. In Europe alone, osteoporosis results in 4.3 million fragility fractures and health care costs reaching €56 billion annually. Due to the limited treatment options and affordability of the medications, less than half of women at high risk of fracture are treated.1 In addition, skeletal related events (SREs) resulting from bone metastases can lead to severe pain, increased risk of death, increased health care costs and reduced quality of life.2 OBODENCE, the company’s first biosimilar in endocrinology, and XBRYK, the company’s third biosimilar in oncology, mark Samsung Bioepis’ 10th and 11th biosimilars available in Europe. They add to the company’s diverse therapeutic portfolio ranging from immunology, oncology, ophthalmology, hematology, and nephrology. About OBODENCE (denosumab) in the European Union Obodence 60 mg solution for injection in pre-filled syringe is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. OBODENCE EU Important Safety Information The EU Summary of Product Characteristics for OBODENCE includes the following Special warning and Precautions: Hypersensitivity Hypocalcaemia Renal impairment Skin infections Osteonecrosis of the jaw (ONJ) Osteonecrosis of the external auditory canal Atypical fractures of the femur Long-term antiresorptive treatment Concomitant treatment with other denosumab-containing medicinal products Hypercalcaemia in paediatric patients These highlights do not include all the information needed to use OBODENCE safely and effectively. Refer to the Summary of Product Characteristics for OBODENCE’s full safety information. About XBRYK (denosumab) in the European Union Xbryk 120 mg solution for injection is indicated for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. XBRYK EU Important Safety Information The EU Summary of Product Characteristics for XBRYK includes the following Special warning and Precautions: Hypersensitivity Hypocalcaemia Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone and in patients with growing skeletons Renal impairment Osteonecrosis of the jaw (ONJ) Osteonecrosis of the external auditory canal Atypical fractures of the femur These highlights do not include all the information needed to use XBRYK safely and effectively. Refer to the Summary of Product Characteristics for XBRYK’s full safety information. # # # About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn. 1 International Osteoporosis Foundation. SCORECARD FOR OSTEOPOROSIS IN EUROPE: SCOPE 2021 Summary Report. Available at: https://www.osteoporosis.foundation/scope-2021. Accessed January 2025. 2 So A, Chin J, Fleshner N, Saad F. Management of skeletal-related events in patients with advanced prostate cancer and bone metastases: Incorporating new agents into clinical practice. Can Urol Assoc J. 2012 Dec;6(6):465-70. doi: 10.5489/cuaj.12149. PMID: 23282666; PMCID: PMC3526633.

上市批准

2025-10-24

·东楠逸锦

【深度】安进公司专利悬崖挑战与战略转型

引言安进公司（Amgen Inc.）作为全球领先的生物技术公司，正面临着前所未有的专利悬崖挑战。截至 2025 年 10 月 21 日，公司股价为 300.18 美元，总市值达 1616.05 亿美元(1)，位列全球第 14 大制药公司。然而，这家成立于 1980 年、拥有超过 21,000 名员工的行业巨头，其核心产品组合正处于关键的专利到期期。专利悬崖的严峻性不容忽视。根据最新数据，2025-2030 年间，全球将有价值约 3500 亿美元的药物失去专利保护，其中前 20 大制药公司承担了 80% 的收入损失风险(149)。对安进而言，其九款核心产品将在 2021-2030 年间陆续失去专利保护，其中Prolia/Xgeva 和 Otezla 合计占公司 2025 年预计总收入的 41%(125)。更令人担忧的是，公司面临 67% 的收入风险，前四大产品均面临专利到期威胁(132)。本研究旨在深入分析安进公司如何应对这一关键挑战，重点关注其核心产品专利到期后的市场影响、生物类似药竞争格局，以及公司的战略转型措施。通过对公司财务数据、产品管线、研发投入和并购策略的全面评估，我们将揭示安进能否成功跨越专利悬崖，维持其在生物技术领域的领导地位。一、安进核心产品专利到期全景图 1.1 专利到期时间轴与市场分布安进的专利悬崖呈现出集中爆发的特征，主要集中在 2025-2028 年这一关键时期。根据最新的专利到期数据，各核心产品的专利保护情况如下：已到期产品： •Enbrel（依那西普）：物质专利于 2012 年到期，但通过制剂和制备方法专利的扩展，目前活性组分制备专利期已延长至 2029 年，制剂专利期最长延长至 2034 年(12)。在美国市场，Enbrel 的新专利将于 2028 年 11 月 22 日到期，届时该药物将已上市 30 年(16)。 2025 年到期产品： •Prolia/Xgeva（地诺单抗）：主要专利已于 2025 年 2 月到期(6)。在美国，专利到期日为 2025 年 2 月 19 日；在欧洲，除法国、意大利、西班牙和英国外，其他国家已于 2022 年 6 月 25 日到期，而这四个主要市场将在 2025 年到期。 •Kyprolis（卡非佐米）：治疗方法专利已于 2025 年 4 月 14 日到期，而化合物专利将于 2027 年 12 月 7 日到期(19)。 2026-2028 年到期产品： •Xgeva：作为地诺单抗的另一个品牌，将于 2026 年到期(101)。 •Otezla（阿普米司特）：专利原定于 2024 年到期，但获得了超过 3 年的专利延期，现定于 2028 年 2 月 16 日到期(23)。法院裁决阻止了仿制药制造商在 2028 年前销售仿制药(8)。 •Enbrel：核心专利将于 2028 年到期(101)。 •Repatha（依洛尤单抗）：专利将于 2028 年 8 月到期(29)。 1.2 生物类似药获批与上市情况随着专利到期，生物类似药的竞争格局正在快速形成。截至 2025 年 6 月，安进核心产品的生物类似药获批情况如下：地诺单抗（Prolia/Xgeva）生物类似药： •Sandoz 的 Jubbonti®/Wyost® 已于 2025 年 6 月 2 日在美国上市，成为首个获批的可互换生物类似药(72)。根据与安进的和解协议，Sandoz 可于 2025 年 5 月 31 日或更早上市(76)。 •在欧洲，已有三家公司的生物类似药获批：Celltrion 的 Stoboclo®/Ozenvelt®（2025 年 2 月）、Samsung Bioepis 的 Obodence™和 Xbryk™（2025 年 2 月）以及 Sandoz 的产品（2024 年 5 月）(74)。依那西普（Enbrel）生物类似药： •Sandoz 的 Erelzi® 早在 2016 年 8 月就获得了 FDA 批准，但由于专利诉讼，预计要到 2029 年才能在美国上市(50)。 •Samsung Bioepis 的 Eticovo® 于 2019 年 4 月获批，但同样受到专利限制。其他产品的生物类似药进展： •Repatha：已有生物类似药在研，如 Henlius 开发的 evolocumab 生物类似药，但仍在专利保护期内(78)。 •Blincyto：Teva 和武田正在开发生物类似药，计划 2026 年进入市场，目前正在进行分子验证研究(84)。二、专利到期对核心产品的市场冲击分析 2.1 Enbrel：从巅峰到衰退的转折 Enbrel 作为安进的明星产品，其市场表现的变化最能体现专利到期和生物类似药竞争的影响。根据公司财报数据，Enbrel 的销售趋势呈现出明显的下滑态势： •2022 年：销售额 36.97 亿美元(122) •2023 年：销售额 36.97 亿美元(122) •2024 年：销售额 33.2 亿美元，同比下降 10%(63) •2025 年 Q1：销售额 5.1 亿美元，同比下降 10%(124) •2025 年 Q3：销售额 8.25 亿美元，同比下降 20%，主要由 13% 的销售扣除和 12% 的价格下降驱动(115) 欧洲市场的惨烈教训为美国市场提供了预警。在欧洲，安进已经失去了约 25% 的市场份额给 Samsung Bioepis 的生物类似药。法国市场的数据更为惊人，etanercept 生物类似药的渗透率已达 74%。价格方面，欧洲市场的生物类似药竞争导致 Enbrel 和同类产品价格下降了 30%-50%(66)。辉瑞作为 Enbrel 的共同开发者，其分得的收入也呈现下滑趋势。2024 年辉瑞从 Enbrel 分得 6.90 亿美元，同比下降 17%(58)，这进一步印证了该产品面临的市场压力。 2.2 Prolia/Xgeva：下一个面临冲击的重磅产品 Prolia 和 Xgeva 作为地诺单抗的两个品牌，合计占安进 2023 年销售额的 22% 以上(1)，是公司的第一大收入来源。2024 年的数据显示： •Prolia 全年销售额 40.48 亿美元(122) •2025 年 Q4 销售额 12 亿美元，全年 37.9 亿美元 •2025 年 Q1 销售额 11.7 亿美元，同比增长 5% 然而，随着 2025 年 2 月专利到期和 Sandoz 生物类似药的上市，Prolia/Xgeva 的销售前景堪忧。安进管理层在 2025 年 Q1 财报会议上明确指出，预计 2025 年下半年将出现销售侵蚀(128)。考虑到 Enbrel 在欧洲市场的经验，Prolia/Xgeva 可能面临类似的市场份额损失。 2.3 其他核心产品的风险评估除了 Enbrel 和 Prolia/Xgeva，安进的其他核心产品也面临不同程度的专利到期风险： Otezla（阿普米司特）： •2024 年销售额 21.88 亿美元(122) •占 2024 年产品销售额的 6.73% •虽然专利延期至 2028 年，但已面临激烈的市场竞争，2024 年销售额下降 3%，主要由 8% 的价格下降驱动 Repatha（依洛尤单抗）： •2024 年销售额 22.2 亿美元，同比增长 36%(121) •占 2024 年产品销售额的 7.58% •作为 PCSK9 抑制剂，技术结构相对清晰，未来可能面临生物类似药挑战(77) Kyprolis（卡非佐米）： •2024 年销售额 14.03 亿美元(122) •占 2024 年产品销售额的 4.32% •虽然治疗方法专利已到期，但化合物专利保护至 2027 年 12 月，短期内风险相对可控三、安进的战略应对：多管齐下的转型之路 3.1 重磅收购：通过外延式增长填补专利悬崖面对专利悬崖，安进采取了激进的并购策略。2023 年 10 月，公司以 278 亿美元收购 Horizon Therapeutics，这是安进历史上最大的一笔收购(101)。这笔交易的战略意图十分明确：通过获得罕见病药物来弥补核心产品专利到期带来的收入损失。 Horizon 带来的核心资产： •Tepezza（teprotumumab-trbw）：甲状腺眼病治疗药物，2024 年销售额达 18.5 亿美元(139)，成为安进新的增长引擎。2024 年 Q4 销售额 4.6 亿美元，全年近 19 亿美元(114)。 •Krystexxa（pegloticase）：痛风治疗药物，2024 年 Q3 销售额 3.1 亿美元，同比增长 116%。安进在全球静脉用 pegloticase 市场占据 60-65% 的份额(119)。 •Uplizna（inebilizumab-cdon）：视神经脊髓炎谱系疾病治疗药物，2024 年 Q4 销售额 1.01 亿美元，全年 3.79 亿美元。 •Tavneos（avacopan）：抗中性粒细胞胞浆抗体相关性血管炎治疗药物，2024 年 Q4 销售额 8100 万美元，全年 2.96 亿美元，同比增长 111%。通过这笔收购，安进在 2024 年 Q3 实现了 12 亿美元的罕见病产品销售额，这些产品大多处于生命周期早期，有望在未来几年持续增长(115)。 3.2 创新研发：押注下一代重磅产品在内部研发方面，安进展现出了强大的创新能力和资金实力。2024 年，公司研发投入达到创纪录的 60 亿美元，同比增长 25%(108)。公司的研发策略结合了人类遗传学、蛋白质工程和人工智能等前沿技术(106)。最具潜力的在研产品：MariTide（AMG 133） MariTide 是安进在减肥药市场的重磅赌注。作为一种长效肽 - 抗体偶联物，每月或更少频率给药，在 2025 年 6 月公布的 Phase 2 研究中展现出令人瞩目的效果： •非糖尿病肥胖患者：52 周平均体重减轻高达 20%，安慰剂组仅为 2.6% •糖尿病肥胖患者：52 周平均体重减轻高达 17%，安慰剂组仅为 1.4% •更重要的是，52 周时体重减轻尚未达到平台期，提示有进一步减重潜力 MariTide 的差异化优势在于其给药频率。与诺和诺德的 Wegovy（每周注射）相比，MariTide 的每月给药方案有望显著提高患者依从性。目前，公司正在进行 72 周的 Phase 3 MARITIME 慢性体重管理研究，并计划在 2025 年启动动脉粥样硬化性心血管疾病、心力衰竭和阻塞性睡眠呼吸暂停的 Phase 3 研究。其他重要研发进展： •IMDELLTRA（tarlatamab-dlle）：2024 年 5 月获得 FDA 加速批准用于广泛期小细胞肺癌，2024 年 Q3 销售额 3600 万美元，季度环比增长 200%(110) •Tezspire（tezepelumab-ekko）：哮喘治疗药物，2024 年 Q3 销售额 2.69 亿美元，同比增长 67% •Evenity（romosozumab-aqqg）：骨质疏松治疗药物，2024 年 Q3 销售额 3.99 亿美元，同比增长 30% 3.3 生物类似药布局：从防守到进攻面对生物类似药的威胁，安进采取了 **"以其人之道还治其人之身"** 的策略，积极布局生物类似药业务。公司利用其在生物制剂领域的丰富经验，开发了多款生物类似药： •2024 年，安进的生物类似药销售额达到 7 亿美元，同比增长 35% •成功推出了强生 Stelara 的生物类似药 Wezlana，标志着公司在生物类似药领域的突破(140) •继续扩大在肿瘤学和自身免疫疾病领域的生物类似药组合这种策略不仅能够部分抵消原研药专利到期的影响，还能为公司开辟新的收入来源。 3.4 产品组合优化：聚焦高增长领域安进正在重新平衡其产品组合，减少对即将失去专利保护产品的依赖，加大对高增长领域的投入：重点发展领域： 1.罕见病：通过 Horizon 收购，罕见病已成为公司重要的增长引擎。预计到 2030 年，罕见病药物可能贡献公司收入的 25%(126)。 2.肿瘤学：IMDELLTRA、Blincyto 等创新产品展现出强劲增长势头。2024 年，10 个产品实现双位数增长，包括多款肿瘤药物(116)。 3.代谢疾病：MariTide 有望在 2030 年达到 1000 亿美元的肥胖药物市场中占据重要份额。产品生命周期管理： •为即将到期的产品寻找新适应症，如 Otezla 在 2024 年获批用于中重度斑块型银屑病(89) •开发新剂型和给药方案，如 Enbrel 的每周给药方案(44) •通过价格策略和患者支持项目维持市场份额四、财务影响的量化评估与前景展望 4.1 专利悬崖的财务冲击预测基于各产品的销售占比和专利到期时间，我们可以对安进未来几年的财务影响进行量化分析：短期影响（2025-2026 年）： •Prolia/Xgeva 占 2025 年预计收入的 22% 以上(1)，随着生物类似药上市，预计将出现 30-50% 的销售下滑 •Enbrel 占 2024 年销售额的 10.3%(121)，已呈现加速下滑趋势，2025 年 Q1 同比下降 10%(124) •管理层预计 2025 年下半年将出现明显的销售侵蚀，但新增长将抵消大部分损失中长期影响（2027-2030 年）： •到 2030 年，安进面临 67% 的收入风险，前四大产品均将失去专利保护(132) •九款产品将在 2021-2030 年间失去专利保护，累计影响可能超过 100 亿美元 4.2 新增长引擎的贡献评估尽管面临专利悬崖，安进的新增长引擎正在加速运转： 2024 年业绩亮点： •总收入 334.24 亿美元，同比增长 19%(123) •产品销售增长 19%，主要由 23% 的销量增长驱动(123) •21 个产品创下销售记录(123) •自由现金流 104 亿美元，同比增长 41%(123) 2025 年展望：公司对 2025 年保持谨慎乐观，预计： •总收入 343-357 亿美元 •非 GAAP 每股收益 20.00-21.20 美元 •生物类似药销售额预计达到 10 亿美元以上 4.3 关键成功因素与风险提示成功跨越专利悬崖的关键因素： 1.MariTide 的市场成功：作为潜在的重磅产品，MariTide 需要在 2026-2027 年成功上市并快速放量，以弥补 Enbrel 和 Prolia/Xgeva 的收入损失。 2.罕见病产品的持续增长：Tepezza、Krystexxa 等产品需要保持高速增长，特别是 Tepezza 需要从目前的 18.5 亿美元增长到 30 亿美元以上。 3.生物类似药业务的扩张：需要从目前的 7 亿美元增长到 20 亿美元以上，成为重要的收入来源。 4.研发管线的执行力：需要持续推出创新产品，特别是在肿瘤学和罕见病领域。主要风险因素： 1.竞争加剧：在肥胖药物市场，诺和诺德和礼来已经建立了强大的先发优势，MariTide 面临激烈竞争。 2.监管风险：新药审批的不确定性，特别是对于创新药物如 MariTide。 3.执行风险：大规模并购的整合挑战，以及新产品上市的商业化风险。 4.宏观环境：美国《通胀削减法案》的价格谈判压力，可能影响新产品的定价策略。结语安进公司正站在一个关键的十字路口。专利悬崖的挑战是严峻的，2025-2028 年间，公司将失去多款核心产品的专利保护，预计将影响超过 100 亿美元的年收入。Enbrel 在欧洲市场的教训表明，生物类似药的冲击可能比预期更加猛烈。然而，安进的应对策略是全面而富有远见的。通过 278 亿美元收购 Horizon，公司成功获得了 Tepezza 等极具潜力的罕见病药物；通过 60 亿美元的研发投入，培育了 MariTide 等下一代重磅产品；通过生物类似药布局，实现了从防守到进攻的转变。更重要的是，公司正在从一家以成熟产品为主的传统生物技术公司，转型为以创新和罕见病为驱动的新型生物制药企业。对投资者的建议：安进的股票在短期内可能面临波动，特别是 2025 年下半年 Prolia/Xgeva 生物类似药全面上市后。但从长期来看，公司的转型战略是正确的。建议投资者关注以下几个关键指标：(1) MariTide 的临床进展和商业化前景；(2) Tepezza 等罕见病产品的增长轨迹；(3) 生物类似药业务的扩张速度；(4) 研发管线中其他创新产品的进展。对行业观察者的启示：安进的转型之路为整个生物技术行业应对专利悬崖提供了重要借鉴。成功的关键在于：(1) 提前布局，通过并购快速获得新的增长引擎；(2) 持续创新，保持强大的研发能力；(3) 灵活应变，在生物类似药时代找到新的商业模式；(4) 聚焦优势，在核心治疗领域建立领导地位。对公司管理层的建议： 1.加快 MariTide 的开发和上市进程，确保其成为新的增长支柱。 2.深化与医疗机构和支付方的合作，确保新产品的市场准入。 3.优化成本结构，提高运营效率，为转型期提供财务缓冲。 4.加强人才管理，特别是在创新研发和商业化领域吸引顶尖人才。总的来说，虽然专利悬崖是安进面临的最大挑战，但公司已经展现出了强大的战略定力和执行能力。如果能够成功执行既定战略，安进有望在 2030 年后以一个更加强大和多元化的姿态出现在全球生物制药舞台上。正如公司 CEO Robert Bradway 所说："2024 年销售和收益的强劲增长反映了我们业务的发展势头。凭借全球强劲表现，我们正在大力投资快速推进的管线，专注于在四个治疗领域提供创新疗法。"(123) 这种信心并非毫无根据，而是建立在扎实的战略布局和执行能力之上。参考资料 [1] Biotech Moat Overview | June 1(pdf) https://www.morningstar.com/content/cs-assets/v3/assets/blt4eb669caa7dc65b2/blt73f6a3d6d16ac04a/Biotech_Moat_Report.pdf?refid=cvent_2023_archive [2] Patent Expiration https://www.drugpatentwatch.com/blog/category/patent-expiration/ [3] Patent Cliff: Can small healthcare firms dictate terms for bigger Pharma on the M&A deals? https://www.acuitykp.com/blog/patent-cliff/ [4] Amgen Update on Patent Litigation Related to Sandoz 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2025-2029年关键生物制剂药物专利到期盘点_CPHI制药在线移动官网 https://m.cphi.cn/news/show-285728.html [36] Top 10 drugs with patents due to expire in the next five years https://www.proclinical.com/blogs/2024-2/top-10-drugs-with-patents-due-to-expire-in-the-next-5-years [37] Biosimilar boom ahead: Patent expirations set to reshape the global biologics market https://www.biospectrumasia.com/analysis/29/25972/biosimilar-boom-ahead-patent-expirations-set-to-reshape-the-global-biologics-market.html [38] BLINCYTO Drug Profile https://www.drugpatentwatch.com/p/biologics/tradename/BLINCYTO [39] Onyx Pharms Amgen Company Profile https://www.drugpatentwatch.com/p/applicant/Onyx+Pharms+Amgen [40] MEMORANDUM in Support re 490 MOTION for Summary Judgment That The Claims Of Patents-In-Suit Are Invalid For Double Patenting Over Amgen 016 Patent filed by F for Amgen Inc. v. F. Hoffmann-LaRoche LTD et al :: Justia Dockets & Filings(pdf) https://cases.justia.com/federal/district-courts/massachusetts/madce/1:2005cv12237/100734/491/0.pdf [41] Amgen Update on Patent Litigation Related to Sandoz Denosumab Biosimilar Products https://www.amgen.com/newsroom/company-statements/amgen-update-on-patent-litigation-related-to-sandoz-denosumab-biosimilar-products [42] U.S. Biosimilar Landscape Deve(pdf) https://www.amerisourcebergen.com/-/media/assets/corporate/global/campaign-pages/cencora-biosimilars-usmarketlandscape-jul25.pdf [43] Medicare Price Negotiations Will Slow Biosimilar Momentum, Widening Market Gap https://www.centerforbiosimilars.com/view/medicare-price-negotiations-will-slow-biosimilar-momentum-widening-market-gap [44] FDA Approves ENBREL for Once-Weekly Dosing https://www.amgen.com/newsroom/press-releases/2003/10/fda-approves-enbrel-for-once-weekly-dosing [45] Pearce IP BioBlast® for the week ending 3 October 2025 https://www.pearceip.law/2025/10/09/pearce-ip-bioblast-for-the-week-ending-3-october-2025/ [46] 专利战升级背后:安进三星再次对簿公堂，生物类似药市场生变?_手机新浪网 https://finance.sina.cn/stock/relnews/us/2024-08-23/detail-inckryae1111936.d.html [47] Amgen Raises Forecast for Year Even as Biosimilars Encroach https://www.ndtvprofit.com/business/amgen-raises-forecast-even-as-biosimilars-encroach-on-top-drugs [48] The Value of Biosimilars and Amgen's Commitment https://wwwext.amgen.com/science/biosimilars/value-of-biosimilars-and-amgens-commitment [49] [重磅]Enbrel生物类似药Erelzi获FDA批准上市 https://m.sohu.com/a/112882965_465956/ [50] Approval and launch dates for US biosimilars https://gabionline.net/reports/Approval-and-launch-dates-for-US-biosimilars [51] Lupin to launch etanercept and pegfilgrastim biosimilars in the US https://gabionline.net/biosimilars/news/Lupin-to-launch-etanercept-and-pegfilgrastim-biosimilars-in-the-US [52] Etanercept biosimilar - Sandoz https://adisinsight.springer.com/drugs/800038107 [53] 中年安进，如何安全度过专利悬崖期? // • 第一核心支柱Prolia将在2025年下半年迎接生物类似药的竞争; • 第二大核心支柱Enbrel增速放缓，... https://xueqiu.com/4376152234/343318494 [54] AMGEN REPORTS THIRD QUARTER FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2023/10/amgen-reports-third-quarter-financial-results [55] Amgen, Merck, Teva Provide First-Quarter Biosimilars Info https://www.centerforbiosimilars.com/view/amgen-merck-teva-provide-first-quarter-biosimilars-reports [56] Amgen Raises Forecast for Year Even as Biosimilars Encroach https://www.ndtvprofit.com/business/amgen-raises-forecast-even-as-biosimilars-encroach-on-top-drugs [57] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2024-financial [58] 2024年全球制药巨头自免业务排名TOP10 https://www.phirda.com/artilce_37907.html?module=trackingCodeGenerator [59] AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2024/10/amgen-reports-third-quarter-2024-financial-results [60] Amgen's 2013 Revenues Increased 8 Percent To $18.7 Billion And Adjusted Earnings Per Share (EPS) Increased 17 Percent To $7.60 https://www.amgen.com/newsroom/press-releases/2014/01/amgens-2013-revenues-increased-8-percent-to-187-billion-and-adjusted-earnings-per-share-eps-increased-17-percent-to-760 [61] AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2024/10/amgen-reports-third-quarter-2024-financial-results [62] Amgen 2024: Building a portfolio with longevity https://www.pharmalive.com/amgen-2024-building-a-portfolio-with-longevity/ [63] 安进2024年财报:业绩超预期，多样化药物组合推动高增长_财富号_东方财富网 https://caifuhao.eastmoney.com/news/20250207185319444019870 [64] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2024-financial [65] Drug Price Trends for ENBREL https://www.drugpatentwatch.com/p/drug-price/drugname/ENBREL [66] 生物类似药欧美市场两重天-四川省医药行业协会 http://scyyhyxh.com/list_51/8209.html [67] +44 20 8123 2220 info@marketpu(pdf) https://pdf.marketpublishers.com/la_merie/competitor-analysis-biosimilar-n-biosuperior-anti-tnf-antibodies-2016-update.pdf [68] Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals https://www.centerforbiosimilars.com/view/eye-on-pharma-korean-drugmakers-impact-in-europe-new-denosumab-eculizumab-deals [69] Korean drugmakers control more than half of European biosimilar market https://openkorea.org/feeds/news/korean-drugmakers-control-more-than-half-of-european-biosimilar-market/ [70] Biosimilars’ Power or Not? https://www.dcatvci.org/features/biosimilars-power-or-not/ [71] SAT0161 PRELIMINARY REAL WORLD DATA ON SWITCHING PATTERNS BETWEEN ETANERCEPT, ITS RECENTLY MARKETED BIOSIMILAR COUNTERPART AND ITS COMPETITOR ADALIMUMAB, USING SWEDISH PRESCRIPTION REGISTRY(pdf) http://gooa.las.ac.cn/apipaperc/api/paper/pdfdown?wid=JA202307270024340WH&roid=RO202307270024340WH [72] New denosumab and ustekinumab biosimilar launches in US, Canada and Japan https://gabionline.net/pharma-news/new-denosumab-and-ustekinumab-biosimilar-launches-in-us-canada-and-japan [73] Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients[1] https://www.thesudburystar.com/globe-newswire/sandoz-launches-first-and-only-interchangeable-denosumab-biosimilars-in-us-providing-new-affordable-treatment-options-for-over-10-million-patients1 [74] CuraTeQ Biologics Completes Biosimilar Denosumab Phase I Trial https://www.pearceip.law/2025/04/10/curateq-biologics-completes-biosimilar-denosumab-phase-i-trial/ [75] Amgen Expands US BPCIA Denosumab Litigation to include Biocon https://www.pearceip.law/2025/06/30/amgen-expands-us-bpcia-denosumab-litigation-to-include-biocon/ [76] Amgen Update on Patent Litigation Related to Sandoz Denosumab Biosimilar Products https://www.amgen.com/newsroom/company-statements/amgen-update-on-patent-litigation-related-to-sandoz-denosumab-biosimilar-products [77] 2025-2029年关键生物制剂药物专利到期盘点_CPHI制药在线移动官网 https://m.cphi.cn/news/show-285728.html [78] Lesser-Known Biosimilar Candidates to Watch For https://www.centerforbiosimilars.com/view/lesser-known-biosimilar-candidates-to-watch-for [79] SEC Filings | Amgen Inc.(pdf) https://amgen-investors.functionize.com/static-files/0000318154-21-000005.pdf;%20filename_=UTF-8''0000318154-21-000005.pdf [80] Competition and price among brand-name drugs in the same class: A systematic review of the evidence https://pmc.ncbi.nlm.nih.gov/articles/PMC6667132/ [81] KYPROLIS Drug Patent Profile https://www.drugpatentwatch.com/p/tradename/KYPROLIS [82] BRIEF—China’s Hansoh files for approval of generic Kyprolis https://www.thepharmaletter.com/in-brief/brief-china-s-hansoh-files-for-approval-of-generic-kyprolis [83] Amgen Data To Be Presented At ASCO 2016 Demonstrates More Insights Into Treatment Options For Patients https://www.amgen.com/newsroom/press-releases/2016/05/amgen-data-to-be-presented-at-asco-2016-demonstrates-more-insights-into-treatment-options-for-patients [84] Blincyto Market Size, Share, Growth, and Industry Analysis, By Type (IV Infusion), By Application (B-cell Acute Lymphoblastic Leukemia (ALL), Relapsed/Refractory Cancer), Regional Insights and Forecast to 2033 https://www.marketgrowthreports.com/market-reports/blincyto-market-113987 [85] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2025/02/amgen-reports-fourth-quarter-and-full-year-2024-financial-results [86] Pipeline Report: Oncology Biosimilars to Advance in 2020 https://www.centerforbiosimilars.com/view/pipeline-report-oncology-biosimilars-to-advance-in-2020 [87] Stivarga (regorafenib) https://veri.larvol.com/news/stivarga-regorafenib/drug [88] Amgen Announces Top-Line Results of Vectibix® (panitumumab) Phase 3 Head-to-Head Study Against Erbitux® (cetuximab) in Metastatic Colorectal Cancer https://www.amgen.com/newsroom/press-releases/2013/05/amgen-announces-topline-results-of-vectibix-panitumumab-phase-3-headtohead-study-against-erbitux-cetuximab-in-metastatic-colorectal-cancer [89] Advancing Health Through Innov(pdf) https://www.fda.gov/files/drugs/published/new-drug-therapy-2025-annual-report.pdf [90] Otezla (apremilast) https://www.pharmakb.com/drug-report/apremilast [91] Otezla上市多久? - 1健康 https://www.jiankang1.com/ask/a179602.html [92] OTEZLA Drug Patent Profile https://www.drugpatentwatch.com/p/tradename/OTEZLA [93] Amgen History https://www.amgen.com/about/amgen-history [94] Only 1 patent barrier remains for launch of Amgen's Otezla generics in Korea https://www.koreabiomed.com/news/articleViewAmp.html?idxno=20115 [95] RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY OF MONTHLY MARITIDE PRESENTED AT THE AMERICAN DIABETES ASSOCIATION 85TH SCIENTIFIC SESSIONS https://www.amgen.com/newsroom/press-releases/2025/06/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions [96] 安进AMG 133公布II期结果:52周减重20% - 医药产业专区 - 生物谷 https://news.bioon.com/article/9da785381257.html [97] maridebart cafraglutide (AMG 133) Trials - LARVOL Sigma http://sigma.larvol.com/sigma/product.php?e1=856617&sourcepg=TZP&tab=ott [98] AMGEN PROVIDES STATEMENT ON MARITIDE PHASE 1 DATA https://www.amgen.com/newsroom/press-releases/2024/11/amgen-provides-statement-on-maritide-phase-1-data [99] Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus https://ctv.veeva.com/study/dose-ranging-study-to-evaluate-the-efficacy-safety-and-tolerability-of-amg-133-in-adult-participan [100] Amgen's big reveal of obesity data falls a little flat https://pharmaphorum.com/news/amgens-big-reveal-obesity-data-falls-little-flat [101] 278亿美元超级并购之后，安进仍陷“专利悬崖”之困_财经头条 https://cj.sina.cn/articles/view/6066470577/16996feb1027016dgk [102] Queen Mary Knowledge Group\nTh(pdf) https://www.qmbfs.com/s/Week-9-MA-2023.pdf [103] Amgen concludes $27.8bn acquisition of Horizon Therapeutics https://www.practical-patient-care.com/news/amgen-concludes-27-8bn-acquisition-of-horizon-therapeutics/ [104] Amgen buys Horizon for $27.8 billion in bold step into the rare disease market https://www.cphi-online.com/news/amgen-buys-horizon-for-27-8-billion-in-bold-step-into-the-rare-disease-market/ [105] IMDELLTRA® SIGNIFICANTLY REDUCED RISK OF DEATH BY 40% IN SMALL CELL LUNG CANCER PATIENTS https://www.amgen.com/newsroom/press-releases/2025/06/imdelltra-significantly-reduced-risk-of-death-by-40-in-small-cell-lung-cancer-patients [106] Research & Development Strategy https://www.amgen.com/science/research-and-development-strategy [107] Amgen's Strategic Momentum at the Bank of America Healthcare Conference: Key Takeaways for Investors https://www.ainvest.com/news/amgen-strategic-momentum-bank-america-healthcare-conference-key-takeaways-investors-2505/ [108] Amgen 2025: The future of American science and innovation https://www.pharmalive.com/amgen-2025-the-future-of-american-science-and-innovation/ [109] Fighting the World's Toughest Diseases https://www.amgen.com/fighting-the-worlds-toughest-diseases [110] FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer#:~:text=On [111] Oncology (Cancer) / Hematologic Malignancies Approval Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications [112] FDA Approves Tarlatamab for Extensive-Stage Small Cell Lung Cancer https://www.medscape.com/viewarticle/fda-approves-tarlatamab-extensive-stage-small-cell-lung-2024a10009ds?src=rss [113] Immunotherapy Drug Tarlatamab Approved for Advanced Small Cell Lung Cancer https://www.cancertodaymag.org/cancer-talk/immunotherapy-drug-tarlatamab-approved-for-advanced-small-cell-lung-cancer/ [114] 安进强劲业绩背后，减肥药开发按下暂停键|仿制药|减肥药开发|安进|治疗|知名企业_手机网易网 http://m.163.com/news/article/JNL90Q6M055619KF.html [115] AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2024/10/amgen-reports-third-quarter-2024-financial-results [116] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://www.amgen.com/newsroom/press-releases/2025/02/amgen-reports-fourth-quarter-and-full-year-2024-financial-results [117] Amgen quarterly profit slips, obesity data on track for late 2024 https://www.streetinsider.com/dr/news.php?id=23558679 [118] Amgen quarterly profit rises 15% as Horizon deal boosts results https://www.xmza.com/research/markets/allNews/reuters/amgen-quarterly-profit-rises-15-as-horizon-deal-boosts-results-53758299 [119] Intravenous Pegloticase Market Size, Production, Sales, Average Product Price, Market Share, Import vs Export https://datavagyanik.com/reports/intravenous-pegloticase-market-research-report-analysis-and-forecast-till-2030/ [120] Hyperuricemia Drugs Global Market Report 2024 https://www.giiresearch.com/report/tbrc1619667-hyperuricemia-drugs-global-market-report.html [121] 安进2024年财报:业绩超预期，多样化药物组合推动高增长 2月4日，安进 $安进(AMGN)$1nbsp;公布了2024年财务业绩，超预期，股价随后大涨6.5%。公司2024年总收入同比... https://xueqiu.com/2319443919/322608173 [122] Amgen 2024: Building a portfolio with longevity https://www.pharmalive.com/amgen-2024-building-a-portfolio-with-longevity/ [123] AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS https://investors.amgen.com/news-releases/news-release-details/amgen-reports-fourth-quarter-and-full-year-2024-financial [124] 中年安进，如何安全度过专利悬崖期? // • 第一核心支柱Prolia将在2025年下半年迎接生物类似药的竞争; • 第二大核心支柱Enbrel增速放缓，... https://xueqiu.com/4376152234/343318494 [125] Patent Cliff: Can small healthcare firms dictate terms for bigger Pharma on the M&A deals? https://www.acuitykp.com/blog/patent-cliff/ [126] Amgen's Strategic Resilience Amid Patent Cliffs: Leveraging Acquisitions and Rare Diseases for Long-Term Growth https://www.ainvest.com/news/amgen-strategic-resilience-patent-cliffs-leveraging-acquisitions-rare-diseases-long-term-growth-2506/ [127] Amgen Reports Second Quarter 2019 Financial Results https://investors.amgen.com/news-releases/news-release-details/amgen-reports-second-quarter-2019-financial-results [128] Amgen Q1: Volume-Driven Sales Rise 11%, Cash Flow Doubles Amidst Biosimilar, IRS Tax Threats https://www.panabee.com/news/amgen-q1-quarterly-earnings-2025 [129] Amgen Reports First Quarter 2021 Financial Results https://www.amgen.com/newsroom/press-releases/2021/04/amgen-reports-first-quarter-2021-financial-results [130] Quarterly Newsletter | Amgen Inc.(pdf) https://amgen-investors.functionize.com/static-files/IR%20Newsletter_Q2_2019_Final.pdf [131] Annual Reports | Amgen Inc.(pdf) https://amgen-investors.functionize.com/static-files/2019%20Annual%20Letter_10-K%20Bookmarked.pdf [132] The $183B Impact of Patent Expirations On Biopharma Giants https://www.worldpharmatoday.com/news/the-183b-impact-of-patent-expirations-on-biopharma-giants/ [133] 2025至2030生物相似行业产业运行态势及投资规划深度研究报告.docx-原创力文档 https://m.book118.com/html/2025/0728/6052055203011205.shtm [134] Vizient Report Projects Price Inflation for Originators With Biosimilars in the Pipeline https://www.centerforbiosimilars.com/view/vizient-report-projects-price-inflation-for-originators-with-biosimilars-in-the-pipeline [135] Biosimilars Regulatory Roundup: May 2025 https://www.centerforbiosimilars.com/view/biosimilars-regulatory-roundup-may-2025 [136] 25 High-Value Drugs Losing Patent Protection in 2025: What It Means for Healthcare https://biopharmaapac.com/analysis/60/5727/25-high-value-drugs-losing-patent-protection-in-2025-what-it-means-for-healthcare.html [137] Global Biosimilars Market Size, Share, Growth, Trends & Analysis Report 2025 https://meditechinsights.com/global-biosimilars-market/ [138] The Stelara Biosimilar Price War: How PBM-Affiliated Private Labels Are Reshaping the Market https://www.drugchannels.net/2025/07/the-stelara-biosimilar-price-war-how.html?m=1 [139] 全球前20大制药公司营收最新排名及分析!涉及强生、罗氏、默沙东、辉瑞等-腾讯新闻 https://news.qq.com/rain/a/20250427A0836Y00 [140] With patent losses on the horizon, Amgen refocuses its business strategy https://www.pharmavoice.com/news/amgen-patent-loss-business-strategy-otezla-enbrel-biosimilars/741572/ [141] Amgen's SWOT analysis: stock outlook amid obesity drug race By Investing.com https://www.investing.com/news/swot-analysis/amgens-swot-analysis-stock-outlook-amid-obesity-drug-race-93CH-3846730 [142] Johnson & Johnson Competitors – Top 10 Major Competitors of Johnson & Johnson | Competitors Analysis https://www.managementnote.com/johnson-johnson-competitors/ [143] Amgen: Business Model, SWOT Analysis, and Competitors 2024 https://pitchgrade.com/companies/amgen [144] 讨论详情 - 雪球 https://xueqiu.com/3692999302/346615026/372553727 [145] Biosimilar boom ahead: Patent expirations set to reshape the global biologics market https://www.biospectrumasia.com/analysis/29/25972/biosimilar-boom-ahead-patent-expirations-set-to-reshape-the-global-biologics-market.html [146] Navigating the Recession and Patent Expirations https://www.pharmexec.com/view/navigating-recession-patent-expirations [147] The Patent Cliff is Coming: What It Means for Pharma Investors in 2025 https://www.crispidea.com/pharma-investing-patent-cliff-2025/ [148] Assessing the Biosimilar Void in the U.S. - IQVIA https://www.iqvia.com/es-mx/insights/the-iqvia-institute/reports-and-publications/reports/assessing-the-biosimilar-void-in-the-us [149] Biopharma Trends 2025(pdf) https://web-assets.bcg.com/80/70/7fee493b4991934742b68e87dc3d/biopharma-trends-focusing-on-innovation-amid-complexity-jan-2025.pdf （注：文档部分内容可能由 AI 生成）

专利到期并购生物类似药

2025-09-09

·药时空

12亿美元！三星生物拿下有史第二大订单

三星生物（Samsung Biologics）9月9日宣布，已与美国某制药公司签订价值12.9464亿美元（约合1.8001万亿韩元）的委托生产（CMO）合同。此次合同是公司创立以来规模第二大的订单，合同期限至2029年12月31日。根据保密条款，客户及产品名称不予公开。根据公开信息，目前三星生物最大的订单是今年1月与一家未具名的欧洲公司签署的，价值2.1万亿韩元（约合14亿美元）。近年来，三星集团依托旗下三星生物制药子公司，在全球的CDMO领域迅速崛起，成为该赛道的新贵。尤其自生物法案以来，三星生物正不断攫取中国一众CDMO企业的市场。 2025 年上半年，Samsung Biologics 合并营收达到 2.588 万亿韩元，同比增长 23%；合并营业利润为 9620 亿韩元，同比大幅增长 47%。其中，作为核心的 CDMO业务表现尤为突出，营收首次在半年度突破 2 万亿韩元大关，录得 2.014 万亿韩元（+36%），营业利润率达 45.0%。生物类似药业务（Bioepis 部门）营收实现了 28%的同比增长，达 8020 亿韩元。业务运营方面，增长动能十分充足。上半年 CDMO 订单承接额达到创纪录的 3.4 万亿韩元，相当于去年全年总额的约 60%。累计订单总额上升至187 亿美元，项目总数达 250 个。生物类似药管线也屡获突破：SB12(bSoliris)在美国上市，SB16(bProlia/bXgeva)在韩国获批，并与日本 NIPRO 就 SB17(bStelara)等管线达成战略合作。基于 Plant 4 的稳健增产和卓越运营，三星生物还将 2025 年全年收入增长指引从 20-25%上调至 25-30%，显示出对下半年业绩的强劲信心。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

生物类似药财报

100 项与地舒单抗生物类似药 (Samsung Bioepis) 相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
代谢性骨病	澳大利亚	Samsung Bioepis AU Pty Ltd	2025-07-09
骨转移癌	韩国	Samsung Bioepis NL B.V.	2025-05-30
恶性肿瘤体液性高钙血症	美国	Samsung Bioepis Co., Ltd.	2025-02-13
骨骼病变	美国	Samsung Bioepis Co., Ltd.	2025-02-13
骨癌	欧盟	Samsung Bioepis NL B.V.	2025-02-12
骨癌	冰岛	Samsung Bioepis NL B.V.	2025-02-12
骨癌	列支敦士登	Samsung Bioepis NL B.V.	2025-02-12
骨癌	挪威	Samsung Bioepis NL B.V.	2025-02-12
骨巨细胞瘤	欧盟	Samsung Bioepis NL B.V.	2025-02-12
骨巨细胞瘤	冰岛	Samsung Bioepis NL B.V.	2025-02-12
骨巨细胞瘤	列支敦士登	Samsung Bioepis NL B.V.	2025-02-12
骨巨细胞瘤	挪威	Samsung Bioepis NL B.V.	2025-02-12
糖皮质激素诱导的骨质疏松症	欧盟	Samsung Bioepis NL B.V.	2025-02-12
糖皮质激素诱导的骨质疏松症	冰岛	Samsung Bioepis NL B.V.	2025-02-12
糖皮质激素诱导的骨质疏松症	列支敦士登	Samsung Bioepis NL B.V.	2025-02-12
糖皮质激素诱导的骨质疏松症	挪威	Samsung Bioepis NL B.V.	2025-02-12
骨质疏松症	欧盟	Samsung Bioepis NL B.V.	2025-02-12
骨质疏松症	冰岛	Samsung Bioepis NL B.V.	2025-02-12
骨质疏松症	列支敦士登	Samsung Bioepis NL B.V.	2025-02-12
骨质疏松症	挪威	Samsung Bioepis NL B.V.	2025-02-12

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04664959 (Phase 3, CTgov)	临床3期	骨质疏松症 \| 绝经期后骨质疏松	457	SB16 (SB16)	鑰簾鑰夢顧壓壓範製糧(獵簾壓襯積壓繭廠鹽鏇) = 鏇蓋憲壓遞艱簾遞齋築網衊顧積衊淵餘憲蓋積 (齋淵壓鑰鬱選壓簾餘壓, 0.250) 更多	-	2025-01-09
				Prolia (Prolia)	鑰簾鑰夢顧壓壓範製糧(獵簾壓襯積壓繭廠鹽鏇) = 獵餘鑰鹹壓築範壓鬱襯網衊顧積衊淵餘憲蓋積 (齋淵壓鑰鬱選壓簾餘壓, 0.254)
NCT04664959 (Pubmed \| J Clin Endocrinol Metab) 人工标引	临床3期	绝经期后骨质疏松	457	SB16	鏇製築構蓋齋憲襯範鹽(膚餘淵鑰窪廠範蓋壓糧) = 夢衊遞願遞鹽觸鏇衊願餘鏇鹹衊選糧齋顧衊製 (夢餘醖選範鏇齋窪壓齋 )	相似	2024-09-07
				Prolia	鏇製築構蓋齋憲襯範鹽(膚餘淵鑰窪廠範蓋壓糧) = 憲醖網獵憲膚鬱醖壓窪餘鏇鹹衊選糧齋顧衊製 (夢餘醖選範鏇齋窪壓齋 )
NCT04664959 (EULAR 12024 \| EULAR 22024) 人工标引	临床3期	绝经期后骨质疏松	457	SB16+SB16	壓壓遞鏇遞淵簾膚鏇艱(齋憲艱膚積鹹夢顧築餘) = 鹽鏇襯繭顧鬱顧壓膚簾艱鏇鏇糧簾窪範製膚衊 (顧糧鹽壓製範觸選獵鬱 )	相似	2024-06-14
				DEN+DEN	-
NCT04664959 (ACR2023) 人工标引	临床3期	绝经期后骨质疏松	457	SB16	遞窪襯廠窪網築鏇網網(簾窪鏇憲壓蓋築繭選齋) = 鹽繭鹽糧構觸觸製淵選簾廠願鬱蓋獵襯鹹獵襯 (範網鏇構製廠壓鏇製築 ) 更多	积极	2023-11-04
				Denosumab	遞窪襯廠窪網築鏇網網(簾窪鏇憲壓蓋築繭選齋) = 餘淵範鬱淵膚窪繭鏇鬱簾廠願鬱蓋獵襯鹹獵襯 (範網鏇構製廠壓鏇製築 ) 更多