To compare the Pharmacokinetics (PK) / Pharmacodynamics(PD)of a single subcutaneous (sc) injection (3.6 mg) of MYL-1401H and G-Lasta in Japanese healthy adult volunteers

开始日期2022-03-17

申办/合作机构-

NCT05573386 / RecruitingN/A

A Single Center, Prospective Study to Compare the Quality and Quantity of the Cellular Content of M-PRP Harvested After Peripheral Mobilization of Progenitor Cells Using Filgrastim Versus Pegfilgrastim

The goal of this prospective, observational study is to compare the quality and quantity of the cellular content of platelet-rich plasma harvested after administering one of two cell-stimulating proteins, filgrastim and pegfilgrastim. The main question it aims to answer is:
• Will participants have a similar cellular content when comparing a 4-day filgrastim treatment to a one-day pegfilgrastim treatment?
Participants will have the following intervention administered:
130mL of blood will be drawn on the first visit after consent and in followup visits after administering treatment (4 days for filgrastim, 7 days for pegfilgrastim)
Half of all participants will receive filgrastim first, followed by pegfilgrastim 8 weeks after filgrastim treatment concludes. The other half will receive the treatments in reverse order
Researchers will compare the quality and quantity of cell content after each treatment administration as well as comparing differences in data dependent on which order treatment was given.

开始日期2021-08-09

申办/合作机构

Andrews Research & Education Foundation, Inc.初创企业

IRCT20180119038433N3 / Suspended临床3期IIT

Comparison of the effect of pegfilgrastim with filgrastim on the neutrophil count of cancer patients under chemotherapy, a randomization clinical trial.

开始日期2020-10-22

申办/合作机构

Semnan University

100 项与培非格司亭生物类似药（Biocon）相关的临床结果

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100 项与培非格司亭生物类似药（Biocon）相关的转化医学

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100 项与培非格司亭生物类似药（Biocon）相关的专利（医药）

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项与培非格司亭生物类似药（Biocon）相关的文献（医药）

2023-02-01·Journal of managed care & specialty pharmacy

Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study

Article

作者: Brown, Joshua D ; Heldermon, Coy D ; Park, Haesuk ; Vouri, Scott M ; Wang, Ching-Yu

BACKGROUND: Real-world evidence on the comparative effectiveness of pegfilgrastim biosimilars compared with the originator product is limited. OBJECTIVE: To compare the risk of febrile neutropenia (FN) among users of pegfilgrastim biosimilars (pegfilgrastim-jmdb and pegfilgrastim-cbqv) and the originator product. METHODS: A retrospective cohort study was conducted using 2019 IBM MarketScan databases to assess comparative effectiveness of pegfilgrastim originator and biosimilars for prevention of FN among patients receiving myelosuppressive chemotherapy. Patients with cancer, including breast, lung, colorectal, esophageal and gastric, pancreatic, prostate, ovarian, and non-Hodgkin lymphomas, initiating myelosuppressive chemotherapy courses were selected. We further selected patients who used pegfilgrastim originator and biosimilars within 3 days of chemotherapy completion. FN-associated hospitalizations were measured by International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes. After 1:1 propensity score matching, we used equivalence (with a margin of 6%) hypothesis tests to compare FN-related hospitalization risk in the first cycle and across all cycles between biosimilars and originator users. RESULTS: A total of 2,045 patients were included, of which 445 (21.8%) used pegfilgrastim-jmdb, 636 (31.1%) used pegfilgrastim-cbqv, and 964 (47.1%) used pegfilgrastim originator. After matching, 13 out of 445 originator users and 17 out of 445 pegfilgrastim-jmdb users developed FN after the first chemotherapy cycle (risk difference was 0.9%; P < 0.001 for equivalence test indicating statistical equivalence). After matching, 14 out of 633 originator users and 16 out of 633 pegfilgrastim-cbqv users developed FN (risk difference was 0.32%; P < 0.001 for equivalence test indicating statistical equivalence). Results across all cycles (including the first cycle) were consistent with that in the first cycle. CONCLUSIONS: In this real-world study of patients with cancer receiving myelosuppressive chemotherapy, there was no difference in FN risk between patients receiving pegfilgrastim originator and biosimilars in the first cycle and across all cycles. These results add further to the current evidence on pegfilgrastim biosimilars and support wider adoption of pegfilgrastim biosimilars among payers, providers, and patients. Future studies assessing the tolerability, side effects, and other safety issues of pegfilgrastim biosimilars are needed.

2022-07-01·Journal of managed care & specialty pharmacy

Patient out-of-pocket and payer costs for pegfilgrastim originator vs biosimilars as primary prophylaxis of febrile neutropenia in the first cycle among a commercially insured population

Article

作者: Brown, Joshua D ; Park, Haesuk ; Heldermon, Coy D ; Vouri, Scott M ; Wang, Ching-Yu

BACKGROUND: It is unknown whether using pegfilgrastim biosimilars is cost saving in a real-world setting. OBJECTIVE: To compare medical costs including pegfilgrastim drug costs and febrile neutropenia (FN) treatment and management costs between pegfilgrastim biosimilars (pegfilgrastim-jmdb, pegfilgrastim-cbqv) and originator users for primary prophylaxis of febrile neutropenia. METHODS: A retrospective cohort study using 2019 IBM MarketScan Commercial and Medicare Supplemental databases was conducted in adult patients with cancer initiating myelosuppressive chemotherapy courses. At least 2 diagnoses of the same cancer (at least 7 days apart) were required within 30 days of the chemotherapy initiation date. Pegfilgrastim (excluding on-body injector) costs included drug costs only (excluding administration fees). FN-related costs included all FN-related health care utilizations that were defined as having neutropenia, fever, or infection diagnosis. Per-patient per-cycle (PPPC) out-of-pocket (OOP) costs, health plan costs, and total costs were compared between originator (excluding on-body injector) and biosimilars users in the first cycle. A generalized linear model and a 2-part model were used. RESULTS: A total of 1,930 patients were included, of whom 884 (45.8%) used pegfilgrastim originator, 427 (22.1%) used pegfilgrastim-jmdb, and 619 (32.1%) used pegfilgrastim-cbqv. Adjusted PPPC OOP pegfilgrastim costs in the first cycle were significantly lower for the biosimilars vs the originator ($182 for pegfilgrastim-jmdb and $159 for pegfilgrastim-cbqv vs $299 for originator, P < 0.0001 for both comparisons). However, there was no difference in health plan costs ($5,783 for pegfilgrastim-jmdb and $5,845 for pegfilgrastim-cbqv vs $5,618 for originator) and total costs. In addition, no difference was observed for adjusted PPPC FN treatment and management OOP costs, health plan costs, and total costs in the first cycle. FN treatment OOP costs were $192 for originator, $197 for pegfilgrastim-jmdb (P = 0.958), and $240 for pegfilgrastim-cbqv (P = 0.680). FN treatment health plan costs were $2,804 for originator, $2,970 for pegfilgrastim-jmdb (P = 0.692), and $2,745 for pegfilgrastim-cbqv (P = 0.879). CONCLUSIONS: In a commercially insured population, using pegfilgrastim biosimilars in the first cycle for primary prophylaxis of FN led to cost savings for patients but not payers. No difference in FN-related costs was observed.

2021-03-01·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy3区 · 医学

Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database

3区 · 医学

Article

作者: Truong, Cong Bang ; Almahasis, Sura ; Qian, Jingjing ; Tanni, Kaniz Afroz

BACKGROUND:

Since the approval and availability of the first biosimilar in 2015 in the United States (US), evidence regarding the post-marketing safety of cancer supportive care biosimilars remains limited.

OBJECTIVE:

The aim was to explore the adverse event (AE) reporting patterns and detect disproportionate reporting signals for cancer supportive care biosimilars in the US compared to their originator biologics.

METHODS:

The US Food and Drug Administration Adverse Event Reporting System database (January 1, 2004-March 31, 2020) was used to identify AE reports for filgrastim, pegfilgrastim, and epoetin alpha by type of product (originator biologics vs. biosimilars) and report characteristics. Plots of AE reports against years were used to reveal the reporting patterns. Disproportionality analyses using reporting odds ratios (RORs) were conducted to detect differences in serious and specific AEs between studied drugs and all other drugs. Breslow-Day tests were used to determine homogeneity between the originator biologic-biosimilar pair RORs for the same AE.

RESULTS:

Total numbers of AEs for all studied biosimilars increased after marketing. More AE reports were from female patients for all of the studied drugs. More AEs for originator biologics and filgrastim biosimilar were reported by health professionals, while the highest proportion of reports came from consumers for pegfilgrastim and epoetin alpha biosimilars (29% and 44.1%, respectively). Signals of disproportionate reporting in serious AEs were detected for a pegfilgrastim biosimilar (Fulphila^®) compared to its originator biologic.

CONCLUSION:

Our findings support the similarity in the signals of disproportionate reporting between cancer supportive care originator biologics and biosimilars, except for Fulphila^®.

项与培非格司亭生物类似药（Biocon）相关的新闻（医药）

2024-05-21

·PRNewswire

Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for Yesafili™. Enters U.S. Ophthalmology Market

BRIDGEWATER, N.J. and BENGALURU, India, May 21, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (US FDA) has approved the Company's first-to-file application for Yesafili™ (aflibercept-jbvf), an interchangeable* biosimilar aflibercept. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA® (aflibercept). Continue Reading YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea® (aflibercept). Data shows that YESAFILI has comparable quality, safety, and efficacy to Eylea®. The FDA approval of YESAFILI as the first interchangeable biological product to Eylea is a significant milestone. Post this The approval of YESAFILI marks Biocon Biologics' expansion into the ophthalmology therapeutic area in the United States following a steady track record of approval in Europe (September 2023) and the United Kingdom (November 2023) where it was the first biosimilar aflibercept to be approved. The Company has secured a launch date in Canada of no later than July 1, 2025, under the terms of a settlement agreement. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. , said: "The FDA approval of YESAFILI (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into Ophthalmology, a new therapeutic area in the United States. YESAFILI is approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. This approval builds on our successful track record of bringing the first interchangeable insulin, SEMGLEE®, the first biosimilar Trastuzumab, OGIVRI®, and the first biosimilar Pegfilgrastim, FULPHILA®, to patients in the United States." Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics Ltd , said: "Biosimilars are crucial for making healthcare more affordable and accessible. YESAFILI will offer ophthalmologists an important new option for patients impacted by macular degeneration and diabetic retinopathy, from a company with a long history of delivering high-quality, science-driven medicines, solely focused on the development and commercialization of biosimilars." There are 19.8 million Americans living with age-related macular degeneration (AMD) in the United States.1 In the U.S., sales of aflibercept were approximately $5.89 billion in 2023.2 Biocon Biologics is a leading global company offering a large portfolio of monoclonal antibodies, insulins, and conjugated proteins. It has achieved several "firsts" in the industry including the first to receive approval in the United States of a biosimilar trastuzumab (OGIVRI®, trastuzumab-dkst) and a biosimilar pegfilgrastim (FULPHILA®, pegfilgrastim-jmdb). Serving over 5.5M patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including four in the United States and six in Canada, with a robust pipeline of 20 biosimilar assets spanning multiple therapy areas. 1 Rein DB, Wittenborn JS, Burke-Conte Z, Gulia R, Robalik T, Ehrlich JR, Lundeen EA, Flaxman AD. Prevalence of Age-Related Macular Degeneration in the United States in 2019. JAMA Ophthalmology. Published Online: November 3, 2022 at: . Accessed April 29, 2024. 2 Regeneron Fourth Quarter and Full Year 2023 Financial and Operating Results. February 2, 2024. * An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of YESAFILI has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. About YESAFILI: The approval for YESAFILI (aflibercept-jbvf) was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that YESAFILI is highly similar to Eylea®. In a Phase 3 INSIGHT Study, YESAFILI was compared with Eylea® in patients with Diabetic Macular Edema. Study demonstrated that there were no clinically meaningful differences between YESAFILI and Eylea in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) WARNINGS AND PRECAUTIONS: YESAFILI is contraindicated in patients with Ocular or periocular infection, Active intraocular inflammation and Hypersensitivity to aflibercept. Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. Please refer to full Prescribing Information for YESAFILI for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or . About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives by enabling affordable access to high quality biosimilars for millions of patients worldwide. It is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. BBL has integrated the acquired global biosimilars business of its long-standing partner Viatris, which is a historic milestone in its value creation journey. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. It has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, BBL is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: ; Follow us on Twitter: @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on Twitter: @bioconlimited for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. YESAFILI™ is a trademark of a Biosimilars Newco Limited, a Biocon Biologics Ltd. company. OGIVRI® and FULPHILA® are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Ltd. company. All other trademarks, registered or unregistered, are the property of their respective owners. SOURCE Biocon Biologics Ltd.

上市批准临床3期并购临床结果生物类似药

2024-03-07

·PRNewswire

United States Biosimilar industry Outlook to 2028, Featuring Pfizer, Amgen, Biogen, Viatris and Coherus Biosciences

DUBLIN, March 7, 2024 /PRNewswire/ -- The "US Biosimilar industry outlook to 2028" report has been added to ResearchAndMarkets.com's offering. The US Biosimilar Industry is anticipated to grow at a CAGR of ~40% in the next five years owing to the cost-effective nature of Biosimilar drugs, rising geriatric population, increasing cases of chronic diseases and growing strategic partnerships. The US Biosimilar market is significantly growing due to various reasons such as rising geriatric population, cost effective nature of Biosimilar drugs, increasing cases of chronic diseases and growing strategic partnerships. Biosimilar drugs also tend to be cost effective. The geriatric population in the US has been constantly rising. The ageing population went from ~25,000 per 100,000 people in 1980s to ~54,000 per 100,000 people in 2020s. Most of the aged people cannot afford original drugs and thus, rising geriatric population raises the demand for Biosimilar drugs. Moreover, the cases of chronic diseases also have been rising in the US over the years. In 2020, there were at least 155 million people living with a chronic disease in the US. Such high number of chronic illness cases also raise the demand for the development of cost-effective medicines in the form of Biosimilar drugs. Key trends by Market Segment: By Drug class: In 2022, Monoclonal Antibodies continued to dominate the US Biosimilar Market. These antibodies can be best described as proteins developed in laboratories that are known to act like actual antibodies present in our blood. The reason behind their dominance is that they have been very successful when it comes to treating life threatening diseases such as cancers. Moreover, a treatment involving these antibodies happens to be more precise than any other treatment. Furthermore, these antibodies are known for activating the immune responses for fighting a particular disease. Due to their success rates and ability to stimulate immune responses, they have gained quite a popularity in the US Biosimilar market. By Application: In 2022, Oncology segment dominated the US Biosimilar market. The cancer cases have been rapidly rising in the United States over the years. In 2022, the United State witnessed almost 2 million cancer cases. The rising cases of cancer also results in the demand for the development of effective and efficient treatment of cancer. Monoclonal Antibodies that are used in Biosimilar drugs also have a 58% success rate in treating cancer. Overall, Biosimilar drugs are widely used in the treatment of various types of cancers such as breast cancer, lung cancer, colorectal cancer, etc. There are many Biosimilar drugs such as Zirabev, Truxima, Ogiviri, Releuko, Fulphila, Retacrit, etc which are used in the effective and efficient treatment of Cancer. By Geography: In 2022, the northern region of US happened to be the dominant segment in the US Biosimilar market. The main reason behind its dominance is the presence of Biosimilar drugs manufacturing companies, presence of many other healthcare companies and top-notch hospitals of the country. This is primarily due to the reason that this region witnesses the major healthcare companies of Biosimilar market in the country such as Amgen, Pfizer, Viartis, Biogen, Coherus Biosciences etc. Overall, there are almost 9000 healthcare companies established in this area. Due to the presence of vast number of companies, this region contributes to the growth of US Biosimilar market greatly. There are also many reputed hospitals located in this area such as Mayo Clinic, Cleveland Clinic, Memorial Sloan Kettering Cancer Centre, Dana Farber Cancer Institute, Hospitals of University of Pennsylvania, Northwestern Memorial Hospital, Barns-Jewish Hospital, etc. As more and more people visits these hospitals, the healthcare professionals get to know the requirements and demands of the Biosimilar drugs thereby accelerating the US Biosimilar Market. Future Outlook: The US Biosimilar Market is anticipated to witness a growth at a CAGR of 40% between the time period 2022-2028 owing to the rising cases of chronic diseases, rising geriatric population and increasing cases of cancer along with growing strategic partnerships among pharmaceutical companies. The prevalence of chronic diseases have been constantly rising in the United States. In 2020, there were at least 155 million people living with a chronic disease. This number is futher projected to reach 165 million and 170 million in 2025 and 2030 respectively. With rapidly rising cases, the demand for biosimilar drugs will be rising thereby driving the US Biosimilar market. The rising geriatric population also increases the demand for Biosimilar drugs. In the US, the geriatric population has increased from 25 per 100 people in the 1980s to 54 per 100 people in 2020. This number is further anticipated to reach 72 per 100 people in 2030s. With rising geriatric population, the demand for Biosimilar drugs rises as aged population is less likely to afford generic drugs. The rising cases of cancer also have resulted in an increased demand for Biosimilar drugs. Cancer has been rapidly rising in the US with around 2 million cases in 2020. The number is only projected to further increase. Moreover, most of the Biosimilar drugs are used in oncology so the rising cases only increases the demand for Biosimilar drugs thereby fueling the US Biosimilar market. Key Topics Covered: 1. Executive Summary 2. US Biosimilar Market Overview 2.1 Taxonomy of the Market 2.2 Industry Value Chain 2.3 Ecosystem 2.4 Government Regulations/Initiatives for the Market 2.5 Growth Drivers of the US Biosimilar Market 2.6 Issues and Challenges of the US Biosimilar Market 2.7 Impact of COVID-19 on US Biosimilar Market 2.8 SWOT Analysis 3.US Biosimilar Market Size, 2017 - 2022 4. US Biosimilar Market Segmentation 4.1 By Drug Class, 2017 - 2022 4.2 By Application 2017 - 2022 4.3 By Regional Split (North/East/West/South/Central), 2017 - 2022 5. Competitive Landscape 5.1 Mergers and Acquisitions, Joint Ventures, Collaborations, and Agreements 5.2 Strategies Adopted by Leading Players 5.3 Company Profiles Pfizer Amgen Biogen Viatris Coherus Biosciences 6. US Biosimilar Market, 2022-2028 7. US Biosimilar Market, Market Segmentation 7.1 By Drug class, 2022 - 2028 7.2 By Application, 2022 - 2028 7.3 By Regional Split (North/East/West/South/Central), 2022 - 2028 8. Analyst Recommendations For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

生物类似药

2023-12-18

·美通社

Biocon Biologics 完成其在约 120 个国家/地区所收购的生物仿制药业务的整合

超过 10 个新兴市场、日本、澳大利亚和新西兰的过渡进程已进入最终阶段马来西亚吉隆坡 2023年12月18日 /美通社/ -- 作为一家独特的全球生物仿制药一体化企业， Biocon Biologics 有着广泛的胰岛素和单克隆抗体产品组合。该公司已成功完成对收购的 Viatris 生物仿制药业务的整合，其在超过 10 个新兴市场以及日本、澳大利亚及新西兰的过渡进程已进入最终阶段。 PFA the banner image 包括 Ogivri® 和 Hertraz® (bTrastuzumab)、Abevmy® (bBevacizumab)、Fulphila® (bPegfilgrastim)、Hulio® (bAdalimumab)、Nepexto® (bEtanercept)、Semglee® (bGlargine) 及 Kirsty® (bAspart) 在内的 Viatris 旗下所有生物仿制药品牌现已整合到 Biocon Biologics 在高级市场和 80 多个新兴市场的商业特许经营业务中。这些产品主要由 Biocon Biologics 开发，并在其位于印度和马来西亚的世界级工厂进行生产。目前，Biocon Biologics 在约 120 个国家/地区建立了强大的商业品牌，其直接业务覆盖美国、加拿大、欧洲，以及印度、阿联酋、沙特阿拉伯、摩洛哥、南非、巴西、马来西亚、泰国和菲律宾等 9 个主要新兴市场国家/地区。 "能够完成我们在 120 个国家/地区所收购业务的成功整合，我感到极为自豪和激动。过渡最终阶段的完成是 Biocon Biologics 向全球一体化公司转型的重大里程碑及标志。我对整个 Biocon Biologics 团队——同事、顾问及合作伙伴表示祝贺和感谢。提前完成无缝过渡，要归功于我们对患者和业务持续性的不懈关注、持续努力和坚定承诺。"—— 首席行政官兼行销总监 Shreehas Tambe 表示。 "我们的团队将借助这一重要里程碑所带来的独特机遇，将 Biocon Biologics 品牌直接推向众多市场。该自主引导的商业模式将使我们与患者、卫生部门、处方医师和付费人之间的联系更加密切。这将使我们有能力以经济实惠的价格为更多患者群体服务，同时为新兴市场的医疗保健系统大幅节约成本，从而实现高品质生物仿制药的公平获取。"—— 新兴市场首席商务官 Susheel Umesh 表示。 Biocon Biologics 已经进行了多项关键领导层任命，重新构建了新的能力和基础设施，并成立了专业化团队，利用自主经营和合作伙伴或分销商主导的商业模式，以满足患者和客户日益增长的需求，确保患者、处方医师、合作伙伴和医疗保健系统之间业务连续性。网站： www.bioconbiologics.com；Twitter： @BioconBiologics；LinkedIn： Biocon Biologics

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA13	DB00019

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
中性粒细胞减少	欧盟	Biosimilar Collaborations Ireland Ltd.	2018-11-20
中性粒细胞减少	冰岛	Biosimilar Collaborations Ireland Ltd.	2018-11-20
中性粒细胞减少	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2018-11-20
中性粒细胞减少	挪威	Biosimilar Collaborations Ireland Ltd.	2018-11-20
粒细胞减少性发热	澳大利亚	Alphapharm Pty Ltd.	2018-08-17
化疗引起的发热性中性粒细胞减少症	美国	Mylan Pharmaceuticals, Inc.	2018-06-04

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适应症	最高研发状态	国家/地区	公司	日期
乳腺癌	临床3期	保加利亚	Mylan, Inc.	2015-03-01
乳腺癌	临床3期	格鲁吉亚	Mylan, Inc.	2015-03-01
乳腺癌	临床3期	德国	Mylan, Inc.	2015-03-01
乳腺癌	临床3期	匈牙利	Mylan, Inc.	2015-03-01
乳腺癌	临床3期	波兰	Mylan, Inc.	2015-03-01
乳腺癌	临床3期	乌克兰	Mylan, Inc.	2015-03-01

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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


ASCO_GI2023	临床2期	食管癌新辅助	67	Day 3 PG-containing DCF	鬱願衊積顧齋範淵夢餘(淵構醖範廠顧衊蓋獵願) = 製積壓艱窪膚淵構鬱簾網繭窪網簾襯淵顧糧築 (繭鏇衊壓製蓋遞壓觸餘 ) 更多	-	2023-01-24
				No PG DCF	鬱願衊積顧齋範淵夢餘(淵構醖範廠顧衊蓋獵願) = 襯簾鬱鏇鬱積鹽齋簾窪網繭窪網簾襯淵顧糧築 (繭鏇衊壓製蓋遞壓觸餘 ) 更多
ESMO_ASIA2022	N/A	侵袭性非霍奇金淋巴瘤	263	PEG G-CSF	繭鬱壓糧鏇願願鹽積艱(鑰鬱壓範觸窪選簾廠網) = 獵選壓廠襯獵襯膚網襯鏇遞夢夢鹽齋鏇醖構衊 (構遞蓋憲積網艱鑰網鏇 ) 更多	-	2022-12-03
				Non-PEG G-CSF	繭鬱壓糧鏇願願鹽積艱(鑰鬱壓範觸窪選簾廠網) = 壓窪構鑰鏇簾鏇範鬱積鏇遞夢夢鹽齋鏇醖構衊 (構遞蓋憲積網艱鑰網鏇 ) 更多
ASCO_GI2022	N/A	食管癌新辅助	52	DCF with prophylactic pegfilgrastim (D3PG)	構範築築願淵齋鑰製選(築醖鏇遞網網齋積顧壓) = 壓鬱醖範願積網觸艱範餘艱繭夢襯齋襯積構膚 (構衊衊獵蓋鏇糧蓋鬱觸 ) 更多	积极	2022-01-19
				Standard DCF (NPG)	構範築築願淵齋鑰製選(築醖鏇遞網網齋積顧壓) = 襯鹽膚築糧網淵廠製夢餘艱繭夢襯齋襯積構膚 (構衊衊獵蓋鏇糧蓋鬱觸 ) 更多
ASCO2021	N/A	非霍奇金淋巴瘤	100	Pegfilgrastim	鹽積網網夢艱齋衊鏇廠(膚築餘獵鹽糧遞醖顧遞) = 獵淵遞膚獵蓋遞壓獵鹹製鹽簾淵網願淵夢鏇鏇 (壓壓鬱蓋夢選積衊夢製 ) 更多	积极	2021-05-28
				Pegfilgrastim-cbqv	鹹艱膚廠觸製觸鹹遞餘(範網齋憲範醖糧簾遞選) = 艱鏇觸範願遞廠獵繭遞鏇製製製選簾糧齋廠襯 (網製鏇糧憲積網鹽觸願 ) 更多
ASCO2021	N/A	慢性淋巴细胞白血病 \| 淋巴瘤	116	Pegfilgrastim (PFG)	廠構鏇獵膚範築膚夢齋(餘網簾衊淵鹹淵構窪壓) = 鑰鹹齋鑰鑰顧艱製糧襯廠網齋餘積襯選簾鑰鹹 (鏇積築願選憲鏇窪蓋糧 ) 更多	-	2021-05-28
				PFG-cbqv	廠構鏇獵膚範築膚夢齋(餘網簾衊淵鹹淵構窪壓) = 憲廠鹹窪醖鏇築壓製鏇廠網齋餘積襯選簾鑰鹹 (鏇積築願選憲鏇窪蓋糧 ) 更多
ASCO2020	N/A	-	-	Pegfilgrastim	鏇蓋鏇壓構廠範鑰獵蓋(鑰鏇鹹鹹壓遞構廠襯蓋) = 膚顧構製製積積夢鑰糧窪艱獵網遞艱網鏇蓋膚 (觸醖糧夢鹽醖夢顧遞膚 )	积极	2020-05-25
				Biosimilar Pegfilgrastim	簾壓鑰艱衊鑰憲憲積願(鹽鬱夢範襯願鏇齋構衊) = 蓋範齋餘鹽遞積繭夢製憲衊廠選鹹廠選糧鏇壓 (築憲廠網獵製鏇範築製 )
ASCO_GI2020	N/A	胃肠道肿瘤	157	Same-day pegfilgrastim	積觸積網憲餘蓋夢齋齋(鏇繭選構夢齋顧選選艱) = 範齋衊積觸觸淵憲簾廠襯淵壓顧選蓋淵襯窪顧 (選蓋壓憲製窪夢網製糧, 450 ~ 23800)	积极	2020-02-04
ASCO2019	N/A	转移性结直肠癌	-	Pegfilgrastim-treated	襯糧壓鬱憲糧衊範獵艱(憲壓選築選衊窪獵醖餘) = 糧糧蓋鑰簾獵淵製衊顧膚觸範淵蓋壓襯鑰衊積 (網積艱範鏇製蓋製餘構 ) 更多	不佳	2019-05-26
				pegfilgrastim (Peg-untreated)	襯糧壓鬱憲糧衊範獵艱(憲壓選築選衊窪獵醖餘) = 鬱憲獵衊糧積醖網衊構膚觸範淵蓋壓襯鑰衊積 (網積艱範鏇製蓋製餘構 ) 更多
ASCO2019	N/A	前列腺癌	65	As-needed filgrastim (ANF)	齋鏇淵膚蓋遞願糧獵醖(選鹽廠醖淵膚遞構遞齋) = 網鬱餘顧構蓋顧憲醖廠衊構齋壓膚廠憲醖衊艱 (壓繭遞齋鏇蓋齋衊醖衊 ) 更多	积极	2019-05-26
				Prophylactic pegfilgrastim (PPF)	齋鏇淵膚蓋遞願糧獵醖(選鹽廠醖淵膚遞構遞齋) = 憲獵繭淵願構鹹鹹積遞衊構齋壓膚廠憲醖衊艱 (壓繭遞齋鏇蓋齋衊醖衊 ) 更多
NCT02467868 (Pubmed) 人工标引	临床3期	中性粒细胞减少	135	MYL-1401H	簾窪廠鏇顧築蓋顧餘簾(餘淵積淵窪夢糧衊膚觸) = 衊襯鹹糧鹹齋鏇夢遞夢簾遞膚壓繭壓壓獵窪鹹 (構遞膚衊鏇鏇餘廠網衊, 0.93) 更多	相似	2019-05-01
				pegfilgrastim	簾窪廠鏇顧築蓋顧餘簾(餘淵積淵窪夢糧衊膚觸) = 夢壓觸積糧構製淵遞齋簾遞膚壓繭壓壓獵窪鹹 (構遞膚衊鏇鏇餘廠網衊, 1.10) 更多