A Prospective, Multicenter Clinical Study to Assess Safety, Immunogenicity and Efficacy of Ranibizumab (Intas Pharmaceuticals Limited) for the Treatment of Wet AMD (Age Related Macular Degeneration) - NA

开始日期2016-03-21

申办/合作机构

Intas Pharmaceuticals Ltd.

CTRI/2013/10/004063

/ Completed临床3期

A Prospective, Comparative, Assessor Blind, Randomized, Multicenteric Phase III study to compare the safety & efficacy of Ranibizumab of Intas Biopharmaceuticals Ltd. in comparison with Lucentis of Novartis in patients of wet AMD(Age related Macular Degeneration). - NA

开始日期2013-10-20

申办/合作机构

Intas Biopharmaceuticals Ltd.

100 项与雷珠单抗生物类似药(Intas Biopharmaceuticals Ltd.) 相关的临床结果

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100 项与雷珠单抗生物类似药(Intas Biopharmaceuticals Ltd.) 相关的转化医学

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项与雷珠单抗生物类似药(Intas Biopharmaceuticals Ltd.) 相关的文献（医药）

2025-01-01·EUROPEAN JOURNAL OF OPHTHALMOLOGY

Punctate inner choroiditis and choroidal neovascular membrane formation following vitreoretinal surgery: A case report

Article

作者: Prabhu, Vishma ; Mahendradas, Padmamalini ; Venkatesh, Ramesh ; Gandhi, Priyanka ; Hande, Prathiba ; Chhablani, Jay ; Kathare, Rupal

Purpose:

To report a case of punctate inner choroiditis (PIC) and subsequent choroidal neovascular membrane (CNVM) development in a young, high myope following vitreoretinal surgery for rhegmatogenous retinal detachment.

Case Description:

A 44-year-old male with high myopia underwent pars plana vitrectomy for subtotal retinal detachment in the left eye, followed by cataract extraction and silicone oil removal. Three years postoperatively, he presented with blurred vision, and fundus examination revealed PIC lesions at the posterior pole. Spectral-domain optical coherence tomography (SD-OCT) showed characteristic features of PIC, including hyperreflective nodule-like elevations, disrupted ellipsoid and interdigitation zones, retinal pigment epithelium (RPE) elevations and increased choroidal hyper transmission signals.

Results:

Initially, no treatment was initiated, and the patient was monitored. Three years later, the patient experienced further vision loss, and fundus examination showed progression of PIC lesions and new CNVM formation in the left eye. The patient was treated with systemic corticosteroids and an intravitreal anti-VEGF injection (Razumab® 0.5 mg/0.05 ml). Three weeks after the intervention, SD-OCT showed regression of the CNVM, and the patient's visual symptoms improved.

Conclusion:

This case underscores the importance of long-term follow-up and timely intervention in managing PIC, especially in high myopes post-retinal surgery. Early identification and treatment with systemic corticosteroids and anti-VEGF therapy are crucial to preserving visual function and preventing severe complications like CNVM.

2023-02-01·Indian journal of ophthalmology

Efficacy of a biosimilar ranibizumab monotherapy for the treatment of retinopathy of prematurity

Article

作者: Sengupta, Sabyasachi ; Prajapati, Vipul ; Choudhary, Tanvi ; Handa, Ramya ; Chauhan, Wilhemina ; Jahan, Bushra ; Malviya, Sheetal ; Shah, Sonali

Purpose::

To evaluate the efficacy of a biosimilar ranibizumab (Razumab) on outcomes of retinopathy of prematurity (ROP) for the first time.

Methods::

This retrospective study included infants presenting with stage 3+ ROP either in zone 1 or zone 2 posterior or aggressive posterior ROP (APROP). All eligible infants received intravitreal razumab (0.25 mg/0.025 ml) monotherapy. Follow-up was continued monthly till complete retinal vascularization was achieved while retreatment with razumab was given when recurrent neovascularization was noted. In case of no recurrence but incomplete vascularization, laser photocoagulation was done to the residual avascular retina.

Results::

We included 118 eyes of 59 infants with a median gestational age of 30 weeks and median birth weight of 1250 grams. At presentation, APROP was found in 28 eyes (24%) of 14 babies while stage 3 disease was seen in zone 1 in another 28 eyes (24%) and the remaining 62 eyes (52%) had stage 3 ROP in zone 2 posterior region. Complete resolution of ROP along with complete vascularization was seen in 22 eyes (19%) at a median of 55 days (IQR = 31–56 days) and 42 eyes (35%) showed a recurrent neovascularization at a median of 51 days post razumab (IQR = 42–55 days). The cumulative incidence of recurrence of neovascularization (21%, 95% CI = 14%–29%) peaked at seven weeks and was significantly higher in eyes with APROP (43%, 95% CI = 27%–63%) compared to eyes without APROP (13.4%, 95%CI, 8%-22%) (P < 0.001).

Conclusion::

Razumab appears to be safe and effective in treating ROP, with about a third requiring reinjection at seven weeks after the first dose.

2022-09-26·Computational and mathematical methods in medicine

The Effects of Combuxil and Leizumab on Retinal Function and Serum Interleukin-17A in Premature Infants with Retinopathy

Article

作者: Zhou, Li ; Su, Gang ; Ren, Huixuan ; Cai, Shanjun ; Xu, Shunian

Objective. To investigate the effects of Compaximab and raizumab on retinal function and serum interleukin-17A level in retinopathy of prematurity. Methods. Sixty cases of retinopathy of prematurity treated in our hospital from February 2019 to April 2021 were selected. The patients were randomly divided into control group (

n = 30

) and research group (

n = 30

). The control group was treated with Compaq and the research group was treated with razumab. The curative effect, retinal function, incidence of complications, intraocular pressure at different time, and the level of serum interleukin-17A were compared. Results. Compared with the two groups, the curative effect of the research group 93.33% (28/30) was greater than that of the control group 66.67% (20/30), and the difference was statistically significant (

P < 0.05

). Compared with the incidence of complications, the incidence of corneal opacity, lens opacity, preretinal and vitreous hemorrhage, endophthalmitis, and traction retinal detachment in the research group was greatly lower, and the difference was statistically significant (

P < 0.05

). Following the therapy, the IOP of the two groups decreased at different times. The IOP of 1 min, 10 min, and 30 min in the research group was obviously lower, and the difference was statistically significant (

P < 0.05

). Following treatments, the levels of serum IL-17A were decreased. Compared with the control group, the level of serum IL-17A in the research group was greatly downregulated, and the difference was statistically significant (

P < 0.05

). Conclusion. Intravitreal injection of razumab is an effective treatment for retinopathy of prematurity, which can effectively improve the retinal function of infants. The level of serum interleukin-17A can be reduced and intraocular pressure can be regulated, which is safe and effective.

项与雷珠单抗生物类似药(Intas Biopharmaceuticals Ltd.) 相关的新闻（医药）

2025-02-10

·PRNewswire

Bio-Thera Solutions Announces Exclusive Commercialization and License Agreement with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), in the United States of America

GUANGZHOU, China, Feb. 10, 2025 /PRNewswire/ -- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced the company has reached an exclusive commercialization and license agreement with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, for the United States of America. Continue Reading Bio-Thera Solutions Announces Exclusive Commercialization and License Agreement with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), in the United States of America BAT2506 is a proposed golimumab biosimilar developed by Bio-Thera. Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-a), a pro-inflammatory molecule. Binding of golimumab to TNF-a results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. The reference medicine golimumab has been approved in the United States and Europe for several indications, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506. Intas Pharmaceuticals, through its US-specialty division Accord BioPharma, will be responsible for commercializing the product in the United States of America. Bio-Thera will receive an upfront payment of $21 million USD, as well as further development and commercial milestones of up to $143.5 million USD. "Accord BioPharma is a leading biosimilar company in the United States, and we are pleased to establish this commercial partnership with Accord for BAT2506," said Dr. Shengfeng Li, CEO of Bio-Thera. "This partnership will expand Bio-Thera's efforts to bring more immunology biosimilars to patients in USA." "Our exclusive commercialization agreement with Bio-Thera strengthens our biosimilar pipeline, a vital component of our U.S. growth strategy," said Chrys Kokino, U.S. President of Accord. "We're investing heavily in biosimilars through external partnerships plus our own clinical efforts, because we believe in their vast potential to drive patient- and provider-centric solutions. Bio-Thera's global experience makes them an excellent partner." About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including four approved products: QLETLI® and BETAGRIN® (Bevifibatide Citrate Injection) in China, and TOFIDENCE™/ BAT1806 and Avzivi® / Pobevcy® in the US, EU and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). About Intas Pharmaceuticals Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses. Being the most affordable treatment option, Intas' products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies. Eleftha is the latest testament to Intas' Biosimilar for Billions philosophy, fulfilling its commitment to provide quality cancer care to the masses. Intas' biosimilars are manufactured at Intas Pharmaceuticals' state of the art European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat. For more information, visit us at . About Accord BioPharma, Inc. Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com. Bio-Thera Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT2506, or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. 1. Simponi® is a registered trademark of Johnson & Johnson 2. QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd. 3. TOFIDENCE™ is a trademark of Biogen MA Inc. 4. Avzivi® is a registered trademark of Sandoz AG 5. POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd. 6. BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd. Contact Bert E. Thomas IV Phone: +1.410.627.1734 Email: [email protected] SOURCE Bio-Thera Solutions, Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

引进/卖出上市批准

2025-02-10

·百奥泰

百奥泰与Intas Pharmaceuticals就BAT2506（参照欣普尼®戈利木单抗开发的生物类似药）达成在美国市场的合作

百奥泰生物制药股份有限公司（上交所代码：688177）是一家位于中国广州，基于科学而创新的全球性生物制药企业（以下简称“百奥泰”或“公司”）。公司今日宣布已与Intas Pharmaceuticals（以下简称“Intas”）就BAT2506（一款参照欣普尼®戈利木单抗开发的生物类似药）签署授权许可及商业化协议，Intas将拥有BAT2506在美国市场的独占的商业化权益。根据协议条款，百奥泰将负责BAT2506的研发、生产以及商业化供应，Intas将通过其美国子公司Accord BioPharma负责BAT2506在美国市场的商业化。百奥泰可获得总金额最高至1.645亿美元，其中包括2100万美元首付款、累计不超过1.435亿美元里程碑付款，以及净销售额的两位数百分比作为收入分成。百奥泰创始人及总经理李胜峰博士表示：“Accord BioPharma是Intas生物制药在美国商业化的子公司，具有领先的生物制剂商业化能力。我们非常高兴能与Accord BioPharma建立商业合作关系，此次合作将给美国患者提供更多可及、可负担的生物类似药。” Accord BioPharma美国区域总裁Chrys Kokino表示：“与百奥泰达成的独家商业化合作将拓展我们生物类似药的产品管线，也是我们在美国布局发展战略的重要一环。我们相信生物类似药在推动以患者和医疗提供者为中心的解决方案上有巨大的潜力，因此我们正通过外部合作以及自身临床经验，大力投资生物类似药。百奥泰在药品出海及全球商业化有着丰富的经验，会是我们最合适的合作伙伴。” BAT2506是百奥泰根据中国NMPA、美国FDA、欧洲EMA生物类似药相关指导原则开发的戈利木单抗生物类似药。戈利木单抗是靶向TNF-α的抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而抑制TNF-α的活性。目前BAT2506已完成全球III期临床研究且上市许可申请已获欧洲EMA受理。关于百奥泰百奥泰是一家位于中国广州，基于科学而创新的全球性生物制药企业。公司致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人类生命或健康的疾病。作为抗体药物全球开发的领导者，百奥泰已推动多款药物获批上市，其中格乐立®（阿达木单抗）、贝塔宁®（枸橼酸倍维巴肽）已在中国获批上市；托珠单抗（美国、欧洲商品名：TOFIDENCE®）和贝伐珠单抗（美国、欧洲商品名：Avzivi®）已在中美欧三个全球主要市场获批上市。TOFIDENCE®成为第一个由中国药企研发、生产且获得美国FDA批准上市的单克隆抗体药物。公司另有多款候选药物进入后期临床试验，其中肿瘤领域主要聚焦后PD-1时代的肿瘤免疫治疗和抗体药物偶联体（ADC）靶向药物开发。百奥泰始终以患者的福祉作为首要核心价值，通过创新研发，为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。欲了解更多信息，请访问官网www.bio-thera.com，或关注我们的X（@bio_thera_sol）和微信公众号（百奥泰）。 1. 格乐立®是百奥泰的注册商标 2. 普贝希®是百奥泰的注册商标 3. 施瑞立®是百奥泰的注册商标 4. 贝塔宁®是百奥泰的注册商标 5. TOFIDENCE®是渤健的注册商标 6. Avzivi®是山德士的注册商标 7. 欣普尼®是强生公司的注册商标关于Intas Pharmaceuticals (Intas) Intas Pharmaceuticals是印度生物类似药领域的引领者，是印度开发和推出本土生物类似药数量最多的企业之一。Intas向广大群众提供优质的生物类似药已有丰富的经验和历史。作为最具性价比的治疗选择，Intas的多款产品如Neukine（非格司亭）、Pegasta（培非格司亭）、Mabtas（利妥昔单抗）、Razumab（雷珠单抗）和 Bevatas（贝伐珠单抗）都改变了各自疗法的管理模式。Eleftha是Intas “生物类似药造福亿万患者”理念的最新例证，体现了其为大众提供高质量癌症治疗的承诺。Intas 的生物类似药均在其位于印度古吉拉特邦艾哈迈达巴德附近的先进生物技术工厂生产，该工厂已获得欧盟药品生产质量管理规范（EU-GMP）认证。欲了解更多信息，请访问官网www.intaspharma.com。关于Accord Biopharma, Inc. (Accord) Accord BioPharma, Inc.是Intas Pharmaceuticals 在美国的子公司，致力于在肿瘤、自身免疫和重症监护领域提供可负担、可及且以患者为中心的治疗方案。Accord聚焦于改善患者的治疗体验，不仅关注药物的生物学特性，还从患者的角度看待疾病，开发能够深刻影响患者生活的高质量疗法。Accord相信生物类似药能够提高多种生物药物的可及性，这些药物在过去或因高昂的成本而未能惠及更多患者。Accord期待提供业内最丰富的生物类似药产品组合之一。欲了解更多信息，请访问官网AccordBioPharma.com。百奥泰前瞻性声明本新闻稿包含了BAT2506和百奥泰及其产品线相关的前瞻性声明。由于某些重要因素可能会影响公司的实际结果，特此提醒读者注意不要过分依赖该前瞻性声明。这些前瞻性语句包括但不限于包含意愿、将要、可能、潜在性、预测、计划、估计、预期等类似陈述。它们都应被视为百奥泰基于截至本新闻稿发布之日可获得的信息的合理假设，并不保证未来的表现或发展。由于多种因素，实际结果和事件可能与前瞻性声明中包含的信息存在重大差异，这些因素包括但不限于本产品可能不会获得受理或批准，以及药物研究、开发和商业化中固有的风险和不确定性，例如临床前和临床研究的风险和不确定性以及能否获得药政部门的批准。其他风险因素包括生产、分销、营销、竞争、知识产权、药物功效和安全性方面的风险和不确定性，国家及全球财务与医疗状况的变化，公司财务状况的变化以及适用法律法规的变化等。本新闻稿中包含的任何前瞻性声明仅针对截止于作出声明之日的情况。除非法律要求，否则百奥泰没有义务更新本新闻稿中包含的任何前瞻性声明，以反映本新闻稿发布之日以后的新信息和事件，公司观点的改变或其他情况。

生物类似药临床3期上市批准

2024-12-03

·PipelineReview

Accord BioPharma Announces Agreement by Intas Pharmaceuticals, Ltd. to Acquire UDENYCA® (pegfilgrastim-cbqv) Business from Coherus BioSciences, Inc., Unlocking Potential for Continued U.S. Growth

Agreement demonstrates the expanding leadership of Accord BioPharma and Intas in the biosimilar market RALEIGH, NC, USA I December 3, 2024 I Accord BioPharma , Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. (“Intas Pharmaceuticals”), focused on the development of oncology, immunology and critical care therapies, announced today that Intas Pharmaceuticals has signed an agreement to acquire the UDENYCA® (pegfilgrastim-cbqv) business from Coherus BioSciences, Inc. (“Coherus”). UDENYCA is a pegfilgrastim biosimilar to Neulasta® and is typically administered the day after chemotherapy to decrease the incidence of infection as caused by febrile neutropenia. During the 2023 fiscal year, sales of UDENYCA totaled $127.1 million. When final, the acquisition will expand Accord BioPharma’s product portfolio and is expected to position the company for accelerated growth in the biosimilar industry. UDENYCA is the only pegfilgrastim biosimilar approved in the United States currently available in three administration options — prefilled syringe (PFS), autoinjector (AI) and on-body injector (OBI) — providing patients and healthcare providers with choice, control and convenience. Since its launch in 2019, over 300,000 patients have been treated with UDENYCA. “By adding UDENYCA to our growing portfolio of biosimilars, we will strengthen our business footprint in the U.S.” said Chrys Kokino, U.S. President of Accord. “With an expanding presence in the market, we can fuel the internal innovation and external expansion needed to deliver more accessible treatment options to patients.” “In considering our strategic pathways to achieve future growth, acquiring the UDENYCA business in the U.S. is appealing for two reasons: the product’s impressive sales and uptake, and its range of administration options that give patients an opportunity to align their needs with a treatment plan,” said Binish Chudgar, Executive Chairman and Managing Director of Intas Pharmaceuticals. “Having an on-body injector within our portfolio will allow us to provide immune supportive care to patients in a variety of settings, including at home, a benefit to patients who live far away from their care center.” The sale is expected to close in the first quarter of 2025. As part of the acquisition, Accord BioPharma will be excited to welcome employees from Coherus to their team to help inform and expand work around UDENYCA. INDICATION UDENYCA ® is a leukocyte growth factor indicated to: Limitations of Use: UDENYCA ® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis. WARNINGS AND PRECAUTIONS: ADVERSE REACTIONS: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity. To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Full Prescribing Information, including instructions for use, are available at www.UDENYCA.com . About Intas Pharmaceuticals Intas Pharmaceuticals is a pioneer in biosimilars, having developed and launched one of the highest numbers of indigenous biosimilars in India. Intas Pharmaceuticals has a rich history of making quality biosimilars accessible to the masses. Being the most affordable treatment option, Intas’ products like Neukine (filgrastim), Pegasta (Pegfilgrastim), Mabtas (rituximab), Razumab (ranibizumab) and Bevatas (bevacizumab) have transformed the management of their respective therapies. Eleftha is the latest testament to Intas’ Biosimilar for Billions philosophy, fulfilling its commitment to provide quality cancer care to the masses. Intas’ biosimilars are manufactured at Intas Pharmaceuticals’ state of the art European Union- Good Manufacturing Practices (EU-GMP) certified biotechnology plant located near Ahmedabad, Gujarat. For more information, visit us at www.intaspharma.com . About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients’ perspective and develop high-quality therapies that impact patients’ lives. Accord BioPharma believes in the ability of biosimilars to increase access to a number of biologic medicines, that in the past may not have been considered for patients due to their high costs. Accord BioPharma looks forward to providing one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com . About Coherus BioSciences Coherus BioSciences, Inc. is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that is expected to be synergistic with its proven commercial capabilities in oncology. References: SOURCE: Accord BioPharma

上市批准并购免疫疗法

100 项与雷珠单抗生物类似药(Intas Biopharmaceuticals Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	S01LA04	-

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
黄斑变性	印度	Intas Biopharmaceuticals Ltd.	2015-01-01

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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


EURETINA2024	N/A	早产儿视网膜病变	-	Intravitreal Ranbizumab biosimilar injections	淵獵鑰鹽衊廠鬱製選範(簾醖製鹹鏇餘築觸遞網) = five babies expired 憲鑰壓繭夢鹽糧鑰築蓋 (範觸襯遞鬱鬱壓鬱鹹遞 ) 更多	-	2024-09-19
CESAR (APAO2023)	N/A	-	141	Razumab	窪淵繭顧齋選窪觸構積(構簾遞糧鏇顧衊顧壓餘) = 觸築鏇願積網獵齋觸範範衊夢鬱衊鏇鹹蓋顧願 (膚醖鑰膚獵齋遞糧衊壓 )	积极	2023-02-23
APAO2017	N/A	-	-	Razumab (Ranibizumab) (Diabetic Macular Edema (DME))	繭窪糧衊鑰簾窪憲淵鹹(窪鏇膚鹽網憲餘構積廠) = No serious drug-related ocular adverse events were identified 夢繭壓膚窪觸網廠夢願 (鬱網醖鹽鏇齋鏇繭築艱 )	-	2017-03-01
APAO2017	N/A	-	-	Razumab (Ranibizumab) (Neovascular Age-Related Macular Degeneration (AMD))		-	2017-03-01