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 ; Baek, Ki-Hyun ; Mordaka, Robert ; 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）

2026-08-17

·Biotech前瞻

被诺华分拆3年后，山德士为何签下复宏汉霖最多10款药？

8月17日，复宏汉霖与山德士达成战略合作，计划围绕最多10款单抗及ADC生物类似药开展海外开发和商业化。目前已经确定的首批资产包括西妥昔单抗生物类似药HLX05-N、依洛尤单抗生物类似药HLX16、贝利尤单抗生物类似药，以及重组人透明质酸酶HLXTE-HAase1001的选择权。围绕这些资产，复宏汉霖最高可获得3.22亿美元，2026年预计开票金额最高约1.005亿美元。 2025年4月，双方曾就伊匹木单抗生物类似药HLX13在欧美等46个国家和地区开展合作。仅一年多后，合作便从单一产品扩大到多产品组合，山德士也将复宏汉霖纳入其长期生物类似药管线建设。山德士离开诺华独立上市很多人对山德士的印象仍停留在诺华旗下。2023年分拆时，部分报道也使用了“诺华出售山德士”的说法。严格来说，山德士并未被第三方收购。2023年10月，诺华将山德士100%股份以实物股息形式分配给原有股东，山德士随后登陆瑞士证券交易所。诺华转向聚焦创新药，山德士则成为独立经营的仿制药和生物类似药公司。独立之后，生物类似药在山德士业务中的地位持续上升。2025年，公司收入约111亿美元，生物类似药占比达到30%；2026年上半年，生物类似药收入增至19亿美元，占总收入的33%，第二季度按固定汇率计算增长22%。为了覆盖未来一批生物药专利到期机会，山德士正在明显加快外部合作。今年3月，公司刚与Samsung Bioepis签下最多5款生物类似药；此次与复宏汉霖合作后，山德士披露的生物类似药管线增至39款，未来可能扩大至46款。在这一轮管线扩张中，复宏汉霖承担产品开发和生产，山德士获得中国以外主要市场的商业化权益。双方的分工较为清晰：复宏汉霖提供研发、注册和供应能力，山德士负责海外准入、渠道和销售。3.22亿美元对应首批资产，并非全部10款产品按照复星医药公告，首批3款产品对应的首付款、开发里程碑、开发预算里程碑及销售里程碑合计最高3.14亿美元，另有800万美元不可退还的透明质酸酶选择权费。其中，首付款最高7700万美元，开发及开发预算里程碑最高1.60亿美元，销售里程碑最高7700万美元。其余产品仍需后续协商，因此不能将3.22亿美元简单视为最多10款产品的总交易价格。复宏汉霖预计2026年可实现的开票金额最高约1.005亿美元，后续款项仍取决于研发、注册、上市和销售进展。交易还设置了较深的商业利益绑定。除另有约定外，山德士需按照相关产品在合作区域各国净销售额或净利润的40%向复宏汉霖支付分成。复宏汉霖同时保留中国市场权益以及相关开发和生产能力。对于一家已经实现盈利的Biotech而言，这种安排能够兼顾近期现金回报、长期销售收益和生产供应收入。三款早期产品，覆盖超过百亿美元原研市场首批产品覆盖肿瘤、心血管和自身免疫三大领域。 HLX05-N对应西妥昔单抗，目前在中国处于Ⅰ期临床阶段，并已在美国获批开展Ⅰ期研究；依洛尤单抗生物类似药HLX16和贝利尤单抗生物类似药均处于临床前阶段。根据公告引用的IQVIA数据，2025年西妥昔单抗、依洛尤单抗和贝利尤单抗全球销售额分别约为16.96亿、66.02亿和24.75亿美元，合计约107.7亿美元。原研药销售额不能直接换算成生物类似药市场。专利挑战、竞品数量、价格降幅和市场准入均会影响商业空间。不过，三款产品分别进入肿瘤、降脂和自身免疫市场，有助于山德士分散单一治疗领域的风险。更值得关注的是产品阶段。除HLX05-N进入Ⅰ期外，其余两款仍处于临床前，透明质酸酶也处于工艺开发阶段。山德士选择在这一时期签约，表明其评估范围已经延伸至复宏汉霖的分析表征、工艺开发、全球注册和规模化生产体系。透明质酸酶还可以支持部分静脉输注药物向皮下注射转换，潜在应用范围不局限于单一产品。合作框架同时纳入ADC生物类似药及相关成分，也为后续产品扩展留下了空间。复宏汉霖已经完成从研发到商业化的初步闭环 2025年，复宏汉霖实现收入66.67亿元、净利润8.27亿元，连续第三年盈利；全球产品收入达到57.75亿元。其中，汉曲优销售收入约29.65亿元，斯鲁利单抗约14.93亿元。公司已有多款产品进入欧美市场。曲妥珠单抗生物类似药先后获中国、欧盟和美国批准；帕妥珠单抗、地舒单抗等产品也已通过欧美监管审评。生产端累计完成超过千批次商业化GMP生产，并建立了面向多个国家和地区的质量及供应体系。这些经历降低了国际合作方对注册和供应风险的顾虑。山德士在2025年先签下HLX13，随后扩大至多产品合作，也体现出双方合作关系已经经过初步验证。复宏汉霖目前的海外产品收入仍然不高。2025年境外产品收入超过2亿元，虽然同比增长一倍，但与国内业务相比仍有明显差距。欧美市场的支付谈判、医院准入和销售网络建设投入较大，引入山德士可以缩短商业化周期，同时减少自建全球团队的成本。因此，这项合作并不等于复宏汉霖放弃全球化。公司保留中国权益、研发生产和较高比例分成，再利用山德士覆盖约100个国家和地区的商业网络，属于现阶段更具效率的出海路径。国内Biotech开始参与全球药企的管线建设过去的国产药出海多以单品授权为主，交易通常发生在临床疗效信号相对明确之后。此次合作覆盖多款早期产品，山德士还会提前参与开发、注册和商业化规划，合作周期明显拉长。复宏汉霖的角色也从单一资产授权方延伸至产品开发者、生产商和长期供应方。未来收益既包括首付款和里程碑，也包括商业化分成及产品供应收入。这种变化建立在国内生物药产业能力逐步成熟的基础上。部分企业已经拥有符合欧美要求的质量体系、规模化产能、国际注册经验和国内商业化现金流，可以根据产品特点主动配置全球权益，而不再局限于出售单一管线。山德士今年先后与Samsung Bioepis和复宏汉霖签订组合式合作，也反映出全球生物类似药竞争正在向平台化发展。国际药企需要快速补充管线，中国企业则凭借研发效率、制造成本和全球注册能力进入其长期供应体系。总结与展望山德士在2023年完成分拆后，已经成为一家独立上市公司。生物类似药收入占比持续上升，外部合作也成为其扩大管线的重要方式。复宏汉霖此次签下的是一份多产品长期合作框架。目前只有3款产品和1项选择权确定，3.22亿美元也需要随研发和商业化进展逐步兑现。产品阶段较早、生物类似药竞争加剧以及海外价格压力，仍是后续需要面对的风险。接下来应重点观察首批三款产品的临床和注册进度、透明质酸酶选择权是否被行使，以及其余合作产品何时确定。如果首批资产顺利推进，复宏汉霖将进一步验证中国企业在全球生物药研发、生产和供应体系中的价值。

生物类似药抗体药物偶联物专利到期并购

2026-07-24

·BioSpace

Samsung Epis Holdings Reports Second Quarter and Half-Year 2026 Financial Results

Samsung Bioepis reports revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026, recording 6% year-over-year growth Expanding direct commercialization in Europe to five products with the launch of OPUVIZ™ 40 mg/mL vial, a biosimilar to Eylea 1 (aflibercept) First to announce preliminary results from Phase 1, 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda 2 (pembrolizumab) Samsung Epis Holdings continuing to secure next-generation growth engines through establishment of a global R&D hub in China INCHEON, Korea--(BUSINESS WIRE)-- #biosimilars --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced its financial results for the second quarter and first half of fiscal year 2026. “We delivered solid first-half 2026 results, achieving 6% growth year-over-year. This performance demonstrates the resilience of our biosimilar portfolio in the global market," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We remain confident in our growth trajectory; increasing product demand in Europe and the US is expected to be reflected sequentially in the second-half results, which would result in steady business performance for the fiscal year.” Second Quarter and First Half 2026 Results – Samsung Bioepis Samsung Bioepis, a 100% owned subsidiary of Samsung Epis Holdings, recorded revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026. This represents an increase of 45.5 billion KRW (+6%) in revenue and 12.8 billion KRW (+6%) in operating profit compared to the same period last year. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); For the second quarter, the company recorded revenue of 392.2 billion KRW and an operating profit of 86.6 billion KRW; revenue and operating profit decreased by 8.8 billion KRW (-2%) and by 3.2 billion KRW (-4%) respectively compared to the same period last year. [Samsung Bioepis Earnings, KRW billion] H1’25 H1’26 YoY Change Q2’25 Q2’26 YoY Change Revenue 801.6 847.1 45.5 (+6%) 401.0 392.2 -8.8 (-2%) Operating Profit 217.8 230.6 12.8 (+6%) 89.8 86.6 -3.2 (-4%) Business Updates Samsung Bioepis has expanded direct commercialization in Europe to five products with the launch of OPUVIZ (aflibercept) 40 mg/mL vial in May 2026. In the US, the company has expanded its market presence with the introduction of OSPOMYV ® (denosumab-dssb). Furthermore, the company is expanding its commercial footprint in international markets, including Japan where it launched its first biosimilar product in May 2026 through partnership with NIPRO Corporation. The company also announced the expansion of its global development and commercialization agreement with Organon to commercialize PYZCHIVA ® (ustekinumab), a biosimilar referencing Stelara 3 (ustekinumab), in Canada. In June 2026, the company announced preliminary results from Phase 1 and Phase 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda (pembrolizumab). Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda while Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24. Both studies are expected to be completed within 2026. SBE303, the company's first novel antibody-drug conjugate (ADC) candidate, entered the global Phase 1 clinical study in March. SBE303 is engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. Nonclinical characterization of SBE303 was presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting in April, highlighting its anti-tumor efficacy, safety, tolerability pro a promising ability to work in combination with existing immuno-oncology therapies. Second Quarter and First Half 2026 Results – Samsung Epis Holdings Samsung Epis Holdings recorded consolidated revenue of 845.8 billion KRW and an operating profit of 149.3 billion KRW in the first half of 2026, reflecting non-cash accounting adjustments. For the second quarter, the company achieved revenue of 391.9 billion KRW and an operating profit of 58.8 billion KRW. Samsung Epis Holdings is stabilizing its business under the holding company structure based on the solid performance of its core subsidiary, Samsung Bioepis, and established its first overseas R&D base in China to strengthen its novel therapeutic development capabilities. Disclaimer This document contains ‘forward-looking statements’ regarding future expectations, projections, plans, and anticipation. ‘Forward-looking statements’ are matters that pertain to the Company’s future business and financial performance, and are subject to uncertainties such as trends in domestic and international financial markets, including but not limited to fluctuations in exchange rates and/or interest rates. ‘Forward-looking statements,’ by their nature, addresses matters that may be uncertain; actual results may be materially different from those expressed in this document. About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . 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. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . 1 Eylea is a trademark of Bayer AG 2 Keytruda is a trademark of Merck Sharp & Dohme. 3 Stelara is a trademark of Johnson & Johnson Corporation. Contacts Media Contact Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

2026-05-29

·BioSpace

Samsung Bioepis Launches OPUVIZ™ (Aflibercept) 40 mg/mL Vial Across Europe, to Treat Ophthalmic Conditions

OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), will be rolled out across Europe, starting today Launch strengthens Samsung Bioepis ophthalmology portfolio in Europe, after the company began direct commercialization of BYOOVIZ ™ (ranibizumab) 10 mg/mL solution for injection in a vial in January 2026 Marks fifth biosimilar product to be directly commercialized by Samsung Bioepis in Europe OPUVIZ 40 mg/mL solution for injection in pre-filled syringe has obtained positive opinion from the Committee for Medicinal Products for Human use (CHMP) in November 2025, and is expected to be available in the market in the third quarter of this year INCHEON, Korea--(BUSINESS WIRE)-- #Europe --Samsung Bioepis Co., Ltd. today announced the launch of OPUVIZ ™ 40 mg/mL solution for injection in a vial , a biosimilar referencing Eylea 1 (aflibercept), across Europe, starting today. OPUVIZ marks the fifth biosimilar product to be directly commercialized by Samsung Bioepis. It builds on other key biosimilar milestones in Europe this year, including the initiation of direct commercialization of BYOOVIZ™ (ranibizumab) 10 mg/mL solution for injection in a vial, as well as the launch of XBRYK™ (denosumab) 120 mg solution for injection in a vial in January. “We are pleased to launch OPUVIZ in Europe, marking a significant milestone in expanding patient access to ophthalmology treatments,” said Antonio Rito, Vice President and Head of Europe, at Samsung Bioepis. “Leveraging our direct commercialization capabilities, we will work closely with healthcare professionals and payers to facilitate access to this important medicine, so that patients can benefit from quality-assured, safe and effective biosimilar alternatives.” In January 2026, Samsung Bioepis announced that the company signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of its biosimilar to Eylea 2 mg (aflibercept 40 mg/mL solution) in Europe and the Rest of the World (RoW). 2 Samsung Bioepis’s aflibercept biosimilar is also available in the Republic of Korea under the brand name AFILIVU™. About OPUVIZ OPUVIZ contains the active ingredient (aflibercept), a vascular endothelial growth factor (VEGF) inhibitor, acting as a recombinant fusion protein designed to block abnormal blood vessel growth and leakage in the eye. OPUVIZ was first approved as 40 mg/mL solution for injection in a vial by the European Commission (EC) in November 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 for adults for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). 3,4 OPUVIZ 40 mg/mL solution for injection in pre-filled syringe has later obtained positive opinion from the CHMP in November 2025 for the same indications as the vial presentation. OPUVIZ SELECT IMPORTANT SAFETY INFORMATION The safety of OPUVIZ has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine, Eylea. For the complete list of side effects and restrictions of OPUVIZ, see the package leaflet. The most common side effects with OPUVIZ are conjunctival haemorrhage, retinal haemorrhage, reduced vision and eye pain. Other common side effects are vitreous detachment, cataract, vitreous floaters and increased intraocular pressure. Serious injection-related side effects are blindness, endophthalmitis, cataracts, increased intraocular pressure, vitreous haemorrhage and vitreous or retinal detachment. OPUVIZ must not be used in patients who have or are thought to have ocular or periocular infections, or in patients who have severe inflammation inside the eye. BYOOVIZ SELECT IMPORTANT SAFETY INFORMATION The safety of BYOOVIZ has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Lucentis. The most common side effects with ranibizumab are increased intraocular pressure, headache, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, sensation of a foreign body in the eye, increased lacrimation, blepharitis, dry eye, ocular hyperaemia, eye pruritis, arthralgia and nasopharyngitis. Rarely, endophthalmitis, blindness, serious damage to the retina and cataract can occur. BYOOVIZ must not be used in patients who may have an infection of the eye or of the area around the eye, or who have severe inflammation within the eye. For the full list of side effects and restrictions of BYOOVIZ, see the package leaflet. XBRYK SELECT IMPORTANT SAFETY INFORMATION The safety of denosumab in XBRYK has been evaluated and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine, Xgeva. For the complete list of side effects and restrictions with XBRYK, see the package leaflet. The most common side effects with XBRYK include hypocalcaemia, pain in the muscles and bones, dyspnoea and diarrhoea. Other common side effects are development of another form of cancer in patients with advanced cancer, hypophosphataemia, excessive sweating, tooth loss and osteonecrosis in the jaw. Hypocalcaemia mostly occurs within the first 2 weeks of starting treatment and can be severe; however, it can be managed with calcium and vitamin D supplementation. XBRYK must not be used in patients with wounds from dental or mouth surgery that have not yet healed, or in people with severe, untreated hypocalcaemia. DISCLAIMER This press release is intended solely for the purpose of sharing the availability of OPUVIZ in Europe. This document should not be construed as medical advice or as an endorsement of any product or treatment. Regulatory approval status and prescribing information may vary by country; please refer to local product information for any medicinal products mentioned herein. Information in this press release may include data on investigational compounds or unapproved indications. Such information is shared for scientific discussion purposes only and does not represent an assertion of safety or efficacy for any unapproved use. This press release may contain forward-looking statements, including statements regarding clinical development programs, regulatory submissions, potential approvals, and future therapeutic potential. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Forward-looking statements are not guarantees of future performance. Samsung Bioepis undertakes no obligation to update any forward-looking statements contained in this press release. 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 biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . 1 Eylea is a trademark of Regeneron Pharmaceuticals. 2 Samsung Bioepis. “Samsung Bioepis Reaches Settlement Agreement for Eylea (Aflibercept) Biosimilar in Europe and the Rest of the World.” News Release, January 30, 2026. Available at: 3 OPUVIZ EMA Summary of Product Characteristics (SmPC). Available at: (Accessed May 2026) 4 OPUVIZ MHRA Summary of Product Characteristics (SmPC). Available at: (Accessed May 2026) Contacts MEDIA CONTACT Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

引进/卖出上市批准

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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外链

KEGG	Wiki	ATC	Drug Bank
-	-	M05BX04	-

研发状态

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适应症	国家/地区	公司	日期
骨折	加拿大	Samsung Bioepis Co., Ltd.	2026-04-13
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

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临床结果

适应症

分期

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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 (WCO_IOF_ESCEO2026)	临床3期	绝经期后骨质疏松	456	SB16	窪淵遞構襯衊醖壓憲淵(憲鬱簾鹹艱鑰遞積鑰夢): Difference = 0.07 (90.0% CI, -0.82 ~ 0.96) 更多	积极	2026-04-16
				DENOSUMAB
NCT04664959 (Phase 3, CTgov)	临床3期	骨质疏松症 \| 绝经期后骨质疏松	457	SB16 (SB16)	壓鹹襯願範鏇簾齋鏇壓(構願鹽獵糧糧醖壓淵夢) = 蓋顧鏇願鏇製網膚顧繭遞壓積齋壓夢鹽憲鬱艱 (鏇顧餘鑰鹽範壓鏇憲膚, 0.250) 更多	-	2025-01-09
				Prolia (Prolia)	壓鹹襯願範鏇簾齋鏇壓(構願鹽獵糧糧醖壓淵夢) = 觸築壓獵鑰齋簾鹹鏇淵遞壓積齋壓夢鹽憲鬱艱 (鏇顧餘鑰鹽範壓鏇憲膚, 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	鑰選衊遞構繭築壓獵膚(衊製醖窪膚顧網遞淵餘) = 鹹廠壓廠構鏇夢夢積願遞衊願淵窪顧糧醖網鑰 (蓋觸築壓餘壓鏇範糧積 )	相似	2024-09-07
				Prolia	鑰選衊遞構繭築壓獵膚(衊製醖窪膚顧網遞淵餘) = 顧壓觸壓繭餘糧膚鬱衊遞衊願淵窪顧糧醖網鑰 (蓋觸築壓餘壓鏇範糧積 )
NCT04664959 (EULAR 12024 \| EULAR 22024) 人工标引	临床3期	绝经期后骨质疏松	457	SB16+SB16	衊鹽鹽衊獵鹹衊餘糧膚(廠醖鹽網糧憲淵構構糧) = 衊獵網夢鬱廠蓋觸鏇鏇網廠壓壓積獵製簾艱積 (簾範醖範鬱鑰鑰夢製淵 )	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	餘齋鏇構築簾艱積鹹艱(鑰鹽衊鏇窪醖膚鹽壓繭) = 獵鑰顧鑰願構齋衊艱蓋觸艱憲壓鬱憲齋顧窪願 (艱鹽窪網鹹淵鏇繭觸淵 ) 更多	积极	2023-11-04
				Denosumab	餘齋鏇構築簾艱積鹹艱(鑰鹽衊鏇窪醖膚鹽壓繭) = 襯範鑰遞膚鑰憲範壓觸觸艱憲壓鬱憲齋顧窪願 (艱鹽窪網鹹淵鏇繭觸淵 ) 更多