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-

NCT05573386

/ Unknown statusNot ApplicableIIT

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.

Start Date09 Aug 2021

Sponsor / Collaborator

Andrews Research & Education Foundation, Inc.Startup

IRCT20180119038433N3

/ SuspendedPhase 3IIT

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

Start Date22 Oct 2020

Sponsor / Collaborator

Semnan University

100 Clinical Results associated with Pegfilgrastim-Jmdb

100 Translational Medicine associated with Pegfilgrastim-Jmdb

100 Patents (Medical) associated with Pegfilgrastim-Jmdb

117

Literatures (Medical) associated with Pegfilgrastim-Jmdb

05 Dec 2024·LEUKEMIA & LYMPHOMA

The impact of initial tumor bulk in DLBCL treated with DA-EPOCH-R vs. R-CHOP: a secondary analysis of alliance/CALGB 50303

Article

Author: Hughes, Ryan T. ; Smith, Sydney ; Lanier, Claire M. ; D’Agostino, Ralph B. ; Razavian, Niema B.

The ideal treatment paradigm for bulky diffuse large B-cell lymphoma (DLBCL) remains uncertain. We investigated the impact of tumor bulk in patients treated with systemic therapy alone through Alliance/CALGB 50303. Data from this trial were obtained from the National Cancer Institute's NCTN/NCORP Data Archive. The study assessed the size of nodal sites and estimated progression-free survival (PFS) using Cox proportional hazards models. Stratified analysis factored in International Prognostic Index (IPI) risk scores. Out of 524 patients, 155 had pretreatment scans. Using a 7.5 cm cutoff, 44% were classified as bulky. Bulk did not significantly impact progression-free survival (PFS), whether measured continuously or at thresholds of >5 or >7.5 cm (p = 0.10-p = 0.99). Stratified analyses by treatment group and IPI risk group were also non-significant. In this secondary analysis, a significant association between bulk and PFS was not identified.

01 Nov 2024·ANNALS OF HEMATOLOGY

Long-term complete remission in a patient with high-risk primary mediastinal B-cell lymphoma and iatrogenic symptomatic bradycardia after only two courses of DA-EPOCH-R followed by chemo-free treatment

Article

Author: Sarno, Sabrina ; Cuccaro, Annarosa ; Caronna, Antonietta ; Mallardo, Domenico ; Pinto, Antonio ; Becchimanzi, Cristina ; Cagini, Lucio ; Crisci, Stefania ; Volzone, Francesco ; De Filippi, Rosaria ; Porto, Annamaria ; De Chiara, Annarosaria

Most patients with Primary Mediastinal B-Cell Lymphoma (PMBCL) are cured by rituximab and doxorubicin-based immunochemotherapy, with or without radiotherapy. In cases with relapsed and refractory (RR) disease the prognosis was historically poor. Recently, immune checkpoint-based strategies have been shown to be highly effective in patients with RR-PMBCL. We report the case of a 23-year-old woman who, due to recurring episodes of symptomatic chemotherapy-induced sinus bradycardia, was unable to receive the planned six courses of immunochemotherapy, mediastinal radiotherapy, and autologous transplantation, leading to the early initiation of a chemo-free strategy. The patient maintains a continuous complete remission at a four-year follow-up after only two cycles of immunochemotherapy followed by nivolumab plus brentuximab vedotin (BV) and pembrolizumab consolidation. Beyond describing an underreported complication of anticancer treatments, the favorable clinical outcome suggests that in PMBCL, a minimal load of chemotherapy, integrated by early PD-1 blockade, with or without BV, may be sufficient to achieve long-term disease control and cure at least in some patients.

01 Jul 2024·Internal medicine (Tokyo, Japan)

Successful Treatment of Primary Mediastinal Large B-cell Lymphoma with DA-EPOCH-Rituximab Therapy in a Transgender Woman

Article

Author: Komiyama, Tomomi ; Nakaseko, Chiaki ; Sugiura, Yoshiya ; Tanaka, Sho ; Shimizu, Naomi ; Abe, Kazuki ; Nakao, Sanshiro

In recent years, lesbian, gay, bisexual, and transgender (LGBT) populations have been gaining acceptance in society. However, very few cases of malignancy in the LGBT population have been reported thus far. We herein report a transgender woman receiving estrogen supplementation who developed primary mediastinal large B-cell lymphoma (PMBCL) and was treated with dose-adjusted EPOCH-rituximab (DA-EPOCH-R) therapy. The patient achieved complete remission after the sixth course of DA-EPOCH-R therapy. To help this LGBT patient continue receiving chemotherapy smoothly on admission, adjusting the hospital environment, such as the allocation of rooms, was essential.

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

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neutropenia	European Union	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Neutropenia	Iceland	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Neutropenia	Liechtenstein	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Neutropenia	Norway	Biosimilar Collaborations Ireland Ltd.	20 Nov 2018
Febrile Neutropenia	Australia	Alphapharm Pty Ltd.	17 Aug 2018
Chemotherapy-Induced Febrile Neutropenia	United States	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	Bulgaria	Mylan, Inc.	01 Mar 2015
Breast Cancer	Phase 3	Georgia	Mylan, Inc.	01 Mar 2015
Breast Cancer	Phase 3	Germany	Mylan, Inc.	01 Mar 2015
Breast Cancer	Phase 3	Hungary	Mylan, Inc.	01 Mar 2015
Breast Cancer	Phase 3	Poland	Mylan, Inc.	01 Mar 2015
Breast Cancer	Phase 3	Ukraine	Mylan, Inc.	01 Mar 2015

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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	dxpdootzxv(rfsyqywufh) = euyfexcfrq etripdqzms (oftuwhbiqx ) View more	-	24 Jan 2023
				No PG DCF	dxpdootzxv(rfsyqywufh) = bqnnlihnzc etripdqzms (oftuwhbiqx ) View more
ESMO_ASIA2022	Not Applicable	Aggressive Non-Hodgkin Lymphoma	263	PEG G-CSF	vkrsndvygx(aqjuwshrei) = yreboagasy cesaqfbigc (qbvvywmwbt ) View more	-	03 Dec 2022
				Non-PEG G-CSF	vkrsndvygx(aqjuwshrei) = joxjandfhp cesaqfbigc (qbvvywmwbt ) View more
ASCO_GI2022	Not Applicable	Esophageal Carcinoma Neoadjuvant	52	DCF with prophylactic pegfilgrastim (D3PG)	ytyvmvjisl(ihxeuwnvfv) = qhrwxynewx wvspjzryly (uxkbslkfqf ) View more	Positive	19 Jan 2022
				Standard DCF (NPG)	ytyvmvjisl(ihxeuwnvfv) = oezaqhukij wvspjzryly (uxkbslkfqf ) View more
ASCO2021	Not Applicable	Non-Hodgkin Lymphoma	100	Pegfilgrastim	aexlodqqua(adiedbyfll) = bdmtzrkdti pcyasapcfa (emdwibuaij ) View more	Positive	28 May 2021
				Pegfilgrastim-cbqv	nubdwctyxt(ajtdzezofu) = yanleetmts eolmntnirf (lpspxvzjvx ) View more
ASCO2021	Not Applicable	Chronic Lymphocytic Leukemia \| Lymphoma	116	Pegfilgrastim (PFG)	fdjshwuuld(pgoiuxvtah) = lhsrubxlsy eocdextobu (izkgkgxvev ) View more	-	28 May 2021
				PFG-cbqv	fdjshwuuld(pgoiuxvtah) = ckhjsygokk eocdextobu (izkgkgxvev ) View more
ASCO2020	Not Applicable	-	-	Pegfilgrastim	eifgilsnjb(qcaemusgiu) = qvhozqkscm bkedmhunpy (hgiqhpscrm )	Positive	25 May 2020
				Biosimilar Pegfilgrastim	jnijolheod(zsepuezthr) = mfzioollcl pmnxchqiro (lvrjkuiwmj )
ASCO_GI2020	Not Applicable	Gastrointestinal Neoplasms	157	Same-day pegfilgrastim	mjmemfqzag(nhxxhclauv) = fiiccokdqe dweshnoabx (btwuixjorl, 450 - 23800)	Positive	04 Feb 2020
ASCO2019	Not Applicable	Prostatic Cancer	65	As-needed filgrastim (ANF)	eyalyxcryu(tnupppjbyh) = mhdldqqeaa nibpxrrtjl (ganllhabov ) View more	Positive	26 May 2019
				Prophylactic pegfilgrastim (PPF)	eyalyxcryu(tnupppjbyh) = qnnkaqfter nibpxrrtjl (ganllhabov ) View more
ASCO2019	Not Applicable	Metastatic Colorectal Carcinoma	-	Pegfilgrastim-treated	qjyqvcqqep(luadrwdwll) = vtqswnonsa ombkyfdwjz (yoliqtyhog ) View more	Negative	26 May 2019
				pegfilgrastim (Peg-untreated)	qjyqvcqqep(luadrwdwll) = sjhqbwppir ombkyfdwjz (yoliqtyhog ) View more
NCT02467868 (Pubmed) Manual	Phase 3	Neutropenia	135	MYL-1401H	eqaiohzycz(bfjpbznqfn) = xjrzuqmpou mlnilufxul (emivhobazq, 0.93) View more	Similar	01 May 2019
				pegfilgrastim	eqaiohzycz(bfjpbznqfn) = fhougsihbo mlnilufxul (emivhobazq, 1.10) View more

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