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

/ CompletedNot 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.

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

Literatures (Medical) associated with Pegfilgrastim-Jmdb

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.

01 Aug 2023·Clinical pharmacology in drug development

Clinical Impact of Antipolyethylene Glycol (PEG) Antibody in Hematological Patients Administered PEGylated‐Granulocyte Colony‐Stimulating Factor

Article

Author: Ishizawa, Keisuke ; Taro, Shimizu ; Nakamura, Shingen ; Ishida, Tatsuhiro ; Okada, Naoto ; Ando, Hidenori ; Goda, Mitsuhiro ; Kitahara, Takashi ; Abe, Masahiro

Abstract:

Polyethylene glycol (PEG) is a polymer covalently attached to proteins to improve their half‐life and efficacy. We previously reported that the PEGylated granulocyte colony‐stimulating factor (PEG‐G‐CSF) is immunogenic, which could adversely impact drug efficacy and safety in animal models. Here, we analyzed the relationship between anti‐PEG antibody titers and the clinical impact of PEG‐G‐CSF in 19 hematological patients. A gradual decrease of anti‐PEG antibody titers from baseline was observed after PEG‐G‐CSF administration. Of the 19 participants, 10 were assessed for noninfectious fever after the first administration of PEG‐G‐CSF and three experienced this reaction. The receiver operating characteristic curve revealed that the cut‐off values of pretreated anti‐PEG IgM and IgG titers for noninfectious fever were set at 5.0 and 96.6 U/mL, respectively. All patients who experienced noninfectious fever had anti‐PEG antibody titers above this cut‐off value (P = .033). An enzyme‐linked immunosorbent assay revealed that some anti‐PEG antibodies in patients with anti‐PEG antibody titers above the cut‐off value reacted with the PEGylated liposome. These results indicate the reactivity of the anti‐PEG antibodies to PEGylated therapeutics observed in hematologic patients and the possibility of the relationship between high titers of anti‐PEG antibodies and the development of adverse events after PEG‐G‐CSF administration.

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.

News (Medical) associated with Pegfilgrastim-Jmdb

11 Apr 2025

·www.pharmaceutical-technology.com

FDA approves Biocon Biologics’ bevacizumab biosimilar for cancer

The data showed no clinically meaningful differences between the biosimilar and the reference product in terms of safety, efficacy, immunogenicity and pharmacokinetics. Credit: Gorodenkoff/Shutterstock. Biocon Biologics has gained approval from the US Food and Drug Administration (FDA) for the intravenous use of Jobevne (bevacizumab-nwgd), a biosimilar to the reference Avastin (bevacizumab). Jobevne is a recombinant humanised monoclonal antibody which functions as a vascular endothelial growth factor inhibitor, targeting the cancer and restricting the supply of blood to tumours. The approval bolsters the company’s biosimilar oncology portfolio in the US, which includes Fulphila (Pegfilgrastim-jmdb) and Ogivri (Trastuzumab-dkst). The company has been marketing bevacizumab under the name Abevmy in Europe, where it was approved in February 2021. It also gained approval in November of the same year in Canada. The FDA approval was supported by a comprehensive package comprising comparative pharmacokinetic, efficacy, nonclinical, functional, safety, analytical and structural data that demonstrated Jobevne’s high similarity to the reference product. In safety, efficacy, immunogenicity and pharmacokinetics, the data showed no clinically meaningful differences between Jobevne and Avastin. Biocon Biologics CEO and managing director Shreehas Tambe stated: “The US FDA approval of Jobevne (bevacizumab-nwgd) is a significant milestone — our seventh biosimilar approved in the US and a strong addition to our robust oncology portfolio. “It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.” Biocon Biologics has commercialised nine biosimilars from a pipeline of 20 products in the US, Australia, Canada, Japan and Europe. Its development pipeline of biosimilar assets spans oncology, ophthalmology, immunology, diabetology and other non-communicable conditions. In August 2024, the company reached a settlement and licence agreement with Janssen Biotech, Janssen Sciences Ireland and Johnson & Johnson (together called Janssen) for the commercialisation of Bmab 1200 (bUstekinumab), a proposed biosimilar to Stelara.

Drug ApprovalLicense out/inImmunotherapy

10 Apr 2025

·pipelinereview.com

Biocon Biologics Announces U.S. FDA Approval for Jobevne™, Biosimilar Bevacizumab, Expanding Its Oncology Portfolio

BRIDGEWATER, NJ, USA and BENGALURU, Karnataka, India I April 10, 2025 I Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics’ biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd. , said: “The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients.” In the U.S., sales of bevacizumab were approximately $2.0 billion in 2023.** Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many “firsts” in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas. About JOBEVNE: The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin® (bevacizumab). The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin® in terms of pharmacokinetics, safety, efficacy, and immunogenicity. INDICATIONS AND USAGE: JOBEVNE is a vascular endothelial growth factor inhibitor indicated for the treatment of: * Limitations of Use: JOBEVNE is not indicated for adjuvant treatment of colon cancer. JOBEVNE is a trademark of Biosimilars Newco Limited, a Biocon Biologics Company. OGIVRI, FULPHILA, SEMGLEE and ABEVMY are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company. BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited. All other trademarks are the property of their respective owners. **Sales projections are based on Biocon Biologics’ analysis of IQVIA 2023 data. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL) , a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company 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. Biocon Biologics has commercialized nine biosimilars from its pipeline of 20 products in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It’s pipeline has several biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website www.bioconbiologics.com ; Follow us on X (formerly 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: www.biocon.com ; Follow-us on X (formerly Twitter ) @bioconlimited and LinkedIn : Biocon for company updates. SOURCE: Biocon Biologics

Drug ApprovalImmunotherapy

09 Apr 2025

·www.pharmaindustrial-india.com

Biocon Biologics Announces USFDA Approval of JOBEVNE Biosimilar for Cancer Treatment

Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd announced that the US Food and Drug Administration (US FDA) has approved Jobevne™ (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin® (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor. The approval of JOBEVNE expands Biocon Biologics' biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: "The U.S. FDA approval of JOBEVNE™ (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients." In the U.S., sales of bevacizumab were approximately USD 2.0 billion in 2023.

Drug ApprovalImmunotherapyBiosimilar

100 Deals associated with Pegfilgrastim-Jmdb

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Neutropenia	European Union	Biocon Biologics Ireland Ltd.	20 Nov 2018
Neutropenia	Iceland	Biocon Biologics Ireland Ltd.	20 Nov 2018
Neutropenia	Liechtenstein	Biocon Biologics Ireland Ltd.	20 Nov 2018
Neutropenia	Norway	Biocon Biologics 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

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	fomgufnyqm(zeyydlplqh) = ufsxlgdtgf wxnhceufer (tuuxewuzpu ) View more	-	24 Jan 2023
				No PG DCF	fomgufnyqm(zeyydlplqh) = cszphscdwp wxnhceufer (tuuxewuzpu ) View more
ESMO_ASIA2022	Not Applicable	Aggressive Non-Hodgkin Lymphoma	263	PEG G-CSF	wkrryinkoh(qcpibolzcy) = kzhvqpzytz hmxwmvtmhc (celoyttnuz ) View more	-	03 Dec 2022
				Non-PEG G-CSF	wkrryinkoh(qcpibolzcy) = fqpphethvn hmxwmvtmhc (celoyttnuz ) View more
ASCO_GI2022	Not Applicable	Esophageal Carcinoma Neoadjuvant	52	DCF with prophylactic pegfilgrastim (D3PG)	eauynyjoge(aarzrjbldh) = pjvjneoyqt cybcwsuuhh (sklqfyyeuq ) View more	Positive	19 Jan 2022
				Standard DCF (NPG)	eauynyjoge(aarzrjbldh) = llofyqcvpx cybcwsuuhh (sklqfyyeuq ) View more
ASCO_GI2020	Not Applicable	Gastrointestinal Neoplasms	157	Same-day pegfilgrastim	lszgylzrto(rzbyljkivu) = ldkjxuaxch iwddhmbhxv (xzkzobcykq, 450 - 23800)	Positive	04 Feb 2020
NCT02467868 (Pubmed) Manual	Phase 3	Neutropenia	135	MYL-1401H	cvyxdnpfyg(hsfgdsdbqy) = mqvdkvedri xbvgzdslzv (spakwuecas, 0.93) View more	Similar	01 May 2019
				pegfilgrastim	cvyxdnpfyg(hsfgdsdbqy) = dfomufrtfw xbvgzdslzv (spakwuecas, 1.10) View more
ASCO2017	Not Applicable	Gastrointestinal Neoplasms	69	Same-day pegfilgrastim administration	byuimhzbyh(nzlczpyajv) = nvhsoljnwd hhfmjqqvtr (fhzjruayee ) View more	Positive	30 May 2017
ASCO2014	Not Applicable	Breast Cancer Adjuvant	55	Pegfilgrastim	yylivishnk(qvkffvbthf) = dugkpmofpi kjxyanxcoo (mfdobbkeny ) View more	-	20 May 2014
				Lenograstim	yylivishnk(qvkffvbthf) = holapfohan kjxyanxcoo (mfdobbkeny ) View more
ASCO2014	Not Applicable	Female Genital Neoplasms	421	Same day administration of pegfilgrastim	igslhepske(zfuetmlikb) = pbarsntvbl csasospsmo (szyagclomb ) View more	-	20 May 2014
				Standard administration of pegfilgrastim	wehmnnvekr(irxahwtomy) = hyvkgyrxpl bpzzpolvos (mfxayejowm ) View more
ASCO2012	Not Applicable	Breast Cancer	-	Balugrastim 40 mg	tihpeirjtd(xuyvrldmwg) = dqjnxjmlfl iyqaptjtos (jhmiwnwgso )	Positive	20 May 2012
				Pegfilgrastim 6 mg	tihpeirjtd(xuyvrldmwg) = qvnwrowanm iyqaptjtos (jhmiwnwgso )
ASCO2012	Phase 2	Extensive stage Small Cell Lung Cancer First line	78	Amrubicin 30 mg/m2 + Carboplatin AUC=5	giubkrvywu(dphhlobymw) = fnfckonoqr ekhojkesuo (hqztmxcziq ) View more	-	20 May 2012

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