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

Start Date17 Mar 2022

Sponsor / Collaborator-

NCT05032183 / RecruitingPhase 1/2IIT

Phase Ib/II Study of the Combination of Low-Intensity Chemotherapy and Tagraxofusp in Patients With Acute Lymphoblastic Leukemia (ALL)

This phase Ib/II trial studies the effects of tagraxofusp and low-intensity chemotherapy in treating patients with CD123 positive acute lymphoblastic leukemia or lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Tagraxofusp consists of human interleukin 3 (IL3) linked to a toxic agent called DT388. IL3 attaches to IL3 receptor positive cancer cells in a targeted way and delivers DT388 to kill them. Chemotherapy drugs, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tagraxofusp with chemotherapy may help control CD123 positive relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma.

Start Date17 Feb 2022

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT04628767 / RecruitingPhase 2/3IIT

A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.

Start Date12 Nov 2021

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Pegfilgrastim-Jmdb

100 Translational Medicine associated with Pegfilgrastim-Jmdb

100 Patents (Medical) associated with Pegfilgrastim-Jmdb

Literatures (Medical) associated with Pegfilgrastim-Jmdb

01 Feb 2023·Journal of managed care & specialty pharmacy

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

Article

Author: 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.

01 Jul 2022·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

Author: 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.

01 Mar 2021·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapyQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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^®.

News (Medical) associated with Pegfilgrastim-Jmdb

21 May 2024

·www.prnewswire.com

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.

Drug ApprovalPhase 3AcquisitionClinical ResultBiosimilar

07 Mar 2024

·www.prnewswire.com

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

Biosimilar

18 Dec 2023

·www.prnewswire.com

Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries

10+ Emerging Markets, Japan & ANZ Transition in Final Phase DUBAI, UAE, Dec. 18, 2023 /PRNewswire/ -- Biocon Biologics, a unique, fully integrated, global biosimilars company with a rich portfolio of insulins and monoclonal antibodies, has successfully concluded the integration of the acquired Viatris biosimilars business with the transition of 10+ Emerging Markets and Japan, Australia and New Zealand in the final phase. Continue Reading PFA the banner image (PRNewsfoto/Biocon Biologics Ltd) All Viatris' biosimilars brands, including Ogivri® & Hertraz® (bTrastuzumab), Abevmy® (bBevacizumab), Fulphila® (bPegfilgrastim), Hulio® (bAdalimumab), Nepexto® (bEtanercept), Semglee® (bGlargine) and Kirsty® (bAspart) are now part of Biocon Biologics' commercial franchise in Advanced Markets and 80+ Emerging Markets. Most of these products have been developed by Biocon Biologics and are being manufactured at its world-class facilities in India and Malaysia. Biocon Biologics will now have a strong commercial footprint across ~120 countries with a direct presence in the U.S., Canada, Europe and 9 key Emerging Market countries of India, UAE, Saudi Arabia, Morocco, South Africa, Brazil, Malaysia, Thailand, and the Philippines. "I am very proud and excited that we have successfully completed the integration of the acquired business across 120 countries. The conclusion of this final wave of transition is a significant milestone and marks the beginning of Biocon Biologics' transformation to a fully integrated global company. I congratulate and thank the entire Biocon Biologics team – colleagues, advisors, and partners. This seamless transition, achieved ahead of schedule, is an outcome of relentless focus, untiring efforts and an unwavering commitment to patients and business continuity." - Shreehas Tambe, CEO & Managing Director. "This milestone presents a unique opportunity for our teams to take Brand Biocon Biologics directly to many markets. This self-led business model will take us closer to the patients, MoHs, prescribers and payers. It will allow us to expand affordable access to larger patient pools and generate significant savings for healthcare systems in these emerging markets, thus enabling equitable access to high quality biosimilars." - Susheel Umesh, Chief Commercial Officer - Emerging Markets. Biocon Biologics has made several key leadership appointments, built new capabilities and infrastructure from the ground up and set up dedicated teams to address the growing needs of patients and customers through self-led and partner or distributor-led commercial models to ensure business continuity for patients, prescribers, partners, and healthcare systems. Website: ; Twitter: @BioconBiologics; LinkedIn: Biocon Biologics SOURCE Biocon Biologics Ltd

AcquisitionExecutive ChangeDrug Approval

100 Deals associated with Pegfilgrastim-Jmdb

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA13	DB00019

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Febrile Neutropenia	EU	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Febrile Neutropenia	IS	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Febrile Neutropenia	LI	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Febrile Neutropenia	NO	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Neutropenia	EU	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Neutropenia	IS	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Neutropenia	LI	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Neutropenia	NO	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Chemotherapy-Induced Febrile Neutropenia	US	Biocon Biologics Ltd. (India)	04 Jun 2018
Chemotherapy-Induced Febrile Neutropenia	US	Mylan Pharmaceuticals, Inc.	04 Jun 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	BG	Mylan, Inc.	01 Mar 2015
Breast Cancer	Phase 3	GE	Mylan, Inc.	01 Mar 2015
Breast Cancer	Phase 3	DE	Mylan, Inc.	01 Mar 2015
Breast Cancer	Phase 3	HU	Mylan, Inc.	01 Mar 2015
Breast Cancer	Phase 3	PL	Mylan, Inc.	01 Mar 2015
Breast Cancer	Phase 3	UA	Mylan, Inc.	01 Mar 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_GI2023	Phase 2	Esophageal Carcinoma Neoadjuvant	67	Day 3 PG-containing DCF	rbtcgjtant(rxzgenvsjb) = xhayoplfyw lufkbzjzok (umsvsbofyk ) View more	-	24 Jan 2023
				No PG DCF	rbtcgjtant(rxzgenvsjb) = vprrjjxtdz lufkbzjzok (umsvsbofyk ) View more
ESMO_ASIA2022	Not Applicable	Aggressive Non-Hodgkin Lymphoma	263	PEG G-CSF	olpmuewfim(ulewocabgc) = wqnxfckxpi ftpsibqhpx (hnfngalyaq ) View more	-	03 Dec 2022
				Non-PEG G-CSF	olpmuewfim(ulewocabgc) = alycigtrlx ftpsibqhpx (hnfngalyaq ) View more
EHA2022	Not Applicable	B-Cell Lymphoma First line	54	DA-EPOCH-RDA-EPOCH-RDA-EPOCH-RDA-EPOCH-RDA-EPOCH-RDA-EPOCH-RDA-EPOCH-R	hvywjtpmye(clpowvmjhw) = mgodpyhzfz wjyomebkpi (drxbdcbglc ) View more	-	10 Jun 2022
ASCO_GI2022	Not Applicable	Esophageal Carcinoma Neoadjuvant	52	DCF with prophylactic pegfilgrastim (D3PG)	hlzivjvnpv(plyqvrottt) = vczczwosse wruayizxsw (juuqzoomgp ) View more	Positive	19 Jan 2022
				Standard DCF (NPG)	hlzivjvnpv(plyqvrottt) = brwjftdlmr wruayizxsw (juuqzoomgp ) View more
ASCO2021	Not Applicable	Non-Hodgkin Lymphoma	100	Pegfilgrastim	stfjmywhth(cmdrtmbaal) = yqyyscdyxd sbwuvkjbcx (uhojcanlao ) View more	Positive	28 May 2021
				Pegfilgrastim-cbqv	kidmbsqpxg(cnauaocsjl) = ipiymfzyoa ewbpzxjadu (ymtsycadyx ) View more
ASCO2021	Not Applicable	Chronic Lymphocytic Leukemia \| Lymphoma	116	Pegfilgrastim (PFG)	psmohiojkc(jjerefwyyy) = bgnjqjsqig mmyxhffrcs (ptyjdpagfr ) View more	-	28 May 2021
				PFG-cbqv	psmohiojkc(jjerefwyyy) = ipktvtmfsp mmyxhffrcs (ptyjdpagfr ) View more
ASCO2020	Not Applicable	-	-	Pegfilgrastim	xgfajjpebd(dwhngtusyo) = rjfunapjbm vqngmdjisf (bemicfpdjh )	Positive	25 May 2020
				Biosimilar Pegfilgrastim	waufqnctez(edguluphyd) = ofpslriqqi cxiwhzoitc (khhyoiqjlw )
ASCO_GI2020	Not Applicable	Gastrointestinal Neoplasms	157	Same-day pegfilgrastim	fnrqfecxvi(rqzalvehki) = ncggbglhta mxyvcepqnx (ovgvyhldug, 450 - 23800)	Positive	04 Feb 2020
DA-EPOCH-R (ICML2019)	Not Applicable	Mediastinal large B-cell lymphoma	44	R-DA-EPOCH-R regimen	gjlbfvicrk(yjjwraekgc) = losihrevux hmjelildki (nrhqklwlhe ) View more	Positive	12 Jun 2019
				Consolidative radiotherapy	gjlbfvicrk(yjjwraekgc) = jbsgabsjqa hmjelildki (nrhqklwlhe ) View more
EUCTR2015-002693-20-BG (GX-G3, ASCO2019)	Phase 2	Neutropenia \| Hemic and Lymphatic Diseases	65	GX-G3 150 μg/kg	joaqzfqaul(jgzutdfjcr) = lnmomfxghf tlmxgxlyea (hdcjuclddx )	Positive	26 May 2019
				GX-G3 250 μg/kg (24h)	joaqzfqaul(jgzutdfjcr) = danmdwuqcf tlmxgxlyea (hdcjuclddx )

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