Delving into the Latest Updates on Pegfilgrastim-Bmez(Clariant Ag) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Pegfilgrastim biosimilar, Pegfilgrastim biosimilar (Sandoz), Pegfilgrastim-bmez

+ [7]

Target

CSF-3R

Action

agonists

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Chemotherapy-Induced Febrile NeutropeniaFebrile NeutropeniaNeutropenia

Inactive Indication

Breast CancerComplicationEarly Stage Breast Carcinoma+ [1]

Originator Organization

Clariant AG

Active Organization

Sandoz GmbH

Sandoz Canada, Inc.Sandoz, Inc.

+ [1]

Inactive Organization

Sandoz AG

Drug Highest PhaseApproved

First Approval Date

European Union (22 Nov 2018),

Febrile NeutropeniaNeutropenia

Regulation-

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Structure/Sequence

Sequence Code 4190

The sequence is quoted from: *****

BACKGROUNDBiosimilars are additional treatment options that are approved based on robust analytical and clinical comparisons with their reference biologic. At the time of initial approval, the full safety profile of a biosimilar is inferred from the reference biologic. Nonetheless, there are still lingering concerns related to the long-term safety of biosimilars. Therefore, we reviewed the post-approval pharmacovigilance data for eight marketed biosimilars from one Marketing Authorization Holder (MAH) to summarize their safety experience in a real-world setting for up to 18 years since their first biosimilar launch.METHODSPost-approval cumulative patient exposure and safety experience for eight Sandoz biosimilars [adalimumab (Hyrimoz^®), epoetin alfa (Binocrit^®), etanercept (Erelzi^®), filgrastim (Zarzio^®), infliximab (Zessly^®), pegfilgrastim (Ziextenzo^®), rituximab (Rixathon^®), and somatropin (Omnitrope^®)] was summarized based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding health authority-authored PSUR assessment reports, where available, as of 31 January 2023. Exposure to all biosimilars was calculated in patient treatment days (PTD) except for rituximab, which was expressed in number of patient doses (PD).RESULTSThe combined post-approval cumulative exposure to seven out of the eight marketed Sandoz biosimilars was more than 1.3 billion PTD and for rituximab more than 1.8 million PD. Overall, a critical analysis of the cumulative safety data of all eight Sandoz biosimilar PSURs concluded that the overall benefit-risk profile of each remains favorable and is consistent with the respective reference biologics.CONCLUSIONSThis is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity.

01 Aug 2023·Annals of Hematology

Correction to: Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high‑dose melphalan and autologous stem cell transplantation

Author: Naso, Virginia ; Pugliese, Marta ; Verduci, Chiara ; Tripepi, Giovanni ; Porto, Gaetana ; Ieracitano, Maria Consuelo ; Moscato, Tiziana ; Gori, Mercedes ; Canale, Filippo Antonio ; Imbalzano, Lucrezia ; Alati, Caterina ; Altomonte, Maria ; Pitino, Annalisa ; Pellicano, Maria ; Irrera, Giuseppe ; Ferreri, Anna ; Santoro, Ludovica ; Loteta, Barbara ; Cuzzocrea, Amelia ; Morabito, Antonella ; Martino, Massimo ; Console, Giuseppe ; Florenzano, Maria Teresa

Multiple myeloma (MM) is the main indication for autologous stem cell transplantation (ASCT).Novel supportive therapies (e.g., granulocyte colony-stimulating factor) have significantly improved post-ASCT-related mortality; however, data on biosimilar pegfilgrastim-bmez (BIO/PEG) in this setting is lacking.This prospective cohort study compared Italian patients with MM who received BIO/PEG post-ASCT with data collected retrospectively from historical control groups from the same center who received either filgrastim-sndz (BIO/G-CSF) or pegfilgrastim (PEG; originator).The primary endpoint was time to neutrophil engraftment (three consecutive days with an absolute neutrophil count ≥ 0.5 x 109/L).Secondary endpoints included incidence and duration of febrile neutropenia (FN).Of the 231 patients included, 73 were treated with PEG, 102 with BIO/G-CSF, and 56 with BIO/PEG.Median age was 60 years and 57.1% were male.Neutrophil engraftment was reached after a median of 10 days in the BIO/PEG and PEG groups and 11 days in the BIO/G-CSF group.Among patients who achieved neutrophil engraftment earlier than this (i.e., day 9), 58% (29/50) were on PEG; of those who achieved it later (i.e., day 11), 80.8% (59/73) were on BIO/G-CSF.FN incidence was higher with BIO/G-CSF (61.4%) vs. PEG (52.1%) or BIO/PEG (37.5%) (p = 0.02 among groups).Patients on BIO/PEG had less frequent grade 2-3 diarrhea (5.5%) compared with BIO/G-CSF (22.5%) or PEG (21.9%); grade 2-3 mucositis was most frequent in the BIO/G-CSF group.In conclusion, pegfilgrastim and its biosimilar displayed an advantageous efficacy and safety profile compared with biosimilar filgrastim in patients with MM post-ASCT.

01 Jul 2023·Annals of Hematology

Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation

Article

Author: Naso, Virginia ; Pugliese, Marta ; Verduci, Chiara ; Tripepi, Giovanni ; Porto, Gaetana ; Ieracitano, Maria Consuelo ; Moscato, Tiziana ; Gori, Mercedes ; Canale, Filippo Antonio ; Imbalzano, Lucrezia ; Alati, Caterina ; Altomonte, Maria ; Pellicano, Maria ; Pitino, Annalisa ; Irrera, Giuseppe ; Ferreri, Anna ; Santoro, Ludovica ; Loteta, Barbara ; Cuzzocrea, Amelia ; Morabito, Antonella ; Martino, Massimo ; Console, Giuseppe ; Florenzano, Maria Teresa

AbstractMultiple myeloma (MM) is the main indication for autologous stem cell transplantation (ASCT). Novel supportive therapies (e.g., granulocyte colony-stimulating factor) have significantly improved post-ASCT-related mortality; however, data on biosimilar pegfilgrastim-bmez (BIO/PEG) in this setting is lacking. This prospective cohort study compared Italian patients with MM who received BIO/PEG post-ASCT with data collected retrospectively from historical control groups from the same center who received either filgrastim-sndz (BIO/G-CSF) or pegfilgrastim (PEG; originator). The primary endpoint was time to neutrophil engraftment (three consecutive days with an absolute neutrophil count ≥ 0.5 × 109/L). Secondary endpoints included incidence and duration of febrile neutropenia (FN). Of the 231 patients included, 73 were treated with PEG, 102 with BIO/G-CSF, and 56 with BIO/PEG. Median age was 60 years and 57.1% were male. Neutrophil engraftment was reached after a median of 10 days in the BIO/PEG and PEG groups and 11 days in the BIO/G-CSF group. Among patients who achieved neutrophil engraftment earlier than this (i.e., day 9), 58% (29/50) were on PEG; of those who achieved it later (i.e., day 11), 80.8% (59/73) were on BIO/G-CSF. FN incidence was higher with BIO/G-CSF (61.4%) versus PEG (52.1%) or BIO/PEG (37.5%) (p = 0.02 among groups). Patients on BIO/PEG had less frequent grade 2–3 diarrhea (5.5%) compared with BIO/G-CSF (22.5%) or PEG (21.9%); grade 2–3 mucositis was most frequent in the BIO/G-CSF group. In conclusion, pegfilgrastim and its biosimilar displayed an advantageous efficacy and safety profile compared with biosimilar filgrastim in patients with MM post-ASCT.

2

News (Medical) associated with Pegfilgrastim-Bmez(Clariant Ag)

13 Feb 2024

·www.businesswire.com

Injectable Hematology Growth Factors Report 2024 - Evolution in Therapeutic Care - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Injectable Hematology Growth Factors Report" has been added to ResearchAndMarkets.com's offering. This report is a comprehensive evaluation and analysis of the technology, products, and participants providing the driving force behind this evolving segment of the healthcare sector. The study is designed to provide drug company decision-makers, drug delivery developers, device designers, healthcare marketers, and supply chain participants with a detailed understanding of the economics, technologies, and opportunities for injection devices designed for patient self-administration. Provider organization business managers, healthcare administrators, and investors will also benefit from this study. Evolution in Therapeutic Care Several recombinant hematologic growth factors or agonists for their receptors have been produced that are useful in treating anemia, neutropenia, and thrombocytopenia, particularly in patients with end-stage renal disease or aplastic anemia or who have received cancer chemotherapy or a hematopoietic cell transplant. The shift in as-supplied packaging from single and multi-use vials to prefilled injection devices will accelerate over the next five years as drug developers move to empower an increasing number of chronically ill patients. The powerful physiological effects of antibodies, hormones, and other biological drugs also increase the need for safety and compliance. What You Will Learn Provides detailed analysis of injectable hematology growth factors delivery and device strategies, and product development factors. Assesses key markets, market dynamics, and market demographics. Analyzes therapeutic demand drivers and evaluates injectable drug products in a number of key therapeutic segments. Provides market data and forecasts. Profiles market sector participants, their product development activities, business strategies, and corporate alliances and affiliations Assesses the importance of alliances and partnerships on drug product commercialization. Evaluates the impact of economic, technology, and regulatory factors Key Topics Covered: Hematology Market Dynamics Competitive Factors Proliferation of Biological Drugs Product Manufacturers Hematology Growth Factors Devices for Administering Injectable Growth Factors Device Selection - Stability and Material Issues Competitive Landscape Prefilled Syringes Pen Injectors Dual Chamber Pens Emerging Devices Injectable Hematology Growth Factors - Product Assessment Abseamed Accofil Aranesp Binocrit Biograstim Biopoin Epoetin Alfa Hexal Eporatio Filgrastim Hexal Fulphila Granix Grastofil Mircera NeoRecormon Neulasta Neupogen Nivestim Ratiograstim Retacrit Rolvedon Silapo Tevagrastim Udenyca (Coherus BioSciences) Zarzio Ziextenzo Market Assessment Anemia Hematopoietic Stem Cell Transplant Advanced Kidney Disease Neutropenia Predonation of Autologous Blood Company Profiles Companies Mentioned AbZ-Pharma Accord Healthcare Amgen Genentech Hexal AG Medice Arzneimittel Mylan International Novartis Pfizer Ratiopharm Rentscler Biotechnologie Roche Sandoz Stada Arzneimittel AG Teva Pharmaceuticals For more information about this report visit https://www.researchandmarkets.com/r/bktosb 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.

ASH

09 Feb 2024

·www.prnewswire.com

Injectable Hematology Growth Factors Report: Shift in As-Supplied Packaging from Single and Multi-use Vials to Prefilled Injection Devices will Accelerate over the Next Five Years

DUBLIN, Feb. 9, 2024 /PRNewswire/ -- The "Injectable Hematology Growth Factors Report" has been added to ResearchAndMarkets.com's offering. Understanding the rapidly advancing sector of injectable hematology growth factors is crucial for stakeholders in the healthcare industry. The latest comprehensive report evaluates the intersection of technology, products, and key players that are shaping this dynamic segment, with particular emphasis on devices designed for patient self-administration. The study presents an in-depth examination of the evolving therapeutic care landscape, highlighting significant developments in the treatment of conditions such as anemia, neutropenia, and thrombocytopenia. It analyzes the shift from traditional vials to prefilled injection devices, a trend that is likely to gain momentum over the following five years, emphasizing the market forces driving this change. Key Highlights from the Report: An in-depth analysis of device strategies and product development factors influencing the injectable hematology growth factors delivery systems. Insight into market dynamics and demographics, underpinning industry growth. An evaluation of therapeutic demand drivers across pivotal segments in healthcare. Comprehensive market data and forecast trends to inform strategic decisions. Profiles of sector participants including business strategies and corporate associations. An assessment of how alliances and partnerships affect the commercialization of drug products. Insights into the economic, technological, and regulatory factors impacting the market. Healthcare administrators, investors, and other stakeholders will benefit from this study's findings that not only chart current market conditions but also project future industry directions. It serves as a critical resource for decision-makers aiming to understand and capitalize on the opportunities presented within this segment. The report's findings are pivotal for a broad spectrum of healthcare professionals, including pharmaceutical decision-makers, device developers, healthcare marketers, and supply chain entities. It is particularly geared towards empowering chronically ill patients and enhancing safety protocols through revolutionary drug delivery methods. Stakeholders are poised to gain substantial insights into the strategies propelling the adoption of injectable hematologic treatments, facilitating informed decisions that align with the compelling trends of self-administered therapeutic care. Discover the Future of Injectable Hematology Treatments As the healthcare industry continues its inexorable march towards more patient-centric and self-managed treatment options, understanding the nuances and intricacies of injectable hematology growth factor treatments becomes ever more critical. The recent report provides these vital insights, demarking a clear view of the path forward. Stay informed on the latest in healthcare advancements and market opportunities. For further information and to explore the depth of this report, interested parties are encouraged to delve into the comprehensive analysis that awaits them. Key Topics Covered: Hematology Market Dynamics Competitive Factors Proliferation of Biological Drugs Product Manufacturers Hematology Growth Factors Devices for Administering Injectable Growth Factors Device Selection - Stability and Material Issues Competitive Landscape Prefilled Syringes Pen Injectors Dual Chamber Pens Emerging Devices Injectable Hematology Growth Factors - Product Assessment Abseamed Accofil Aranesp Binocrit Biograstim Biopoin Epoetin Alfa Hexal Eporatio Filgrastim Hexal Fulphila Granix Grastofil Mircera NeoRecormon Neulasta Neupogen Nivestim Ratiograstim Retacrit Rolvedon Silapo Tevagrastim Udenyca (Coherus BioSciences) Zarzio Ziextenzo Market Assessment Anemia Hematopoietic Stem Cell Transplant Advanced Kidney Disease Neutropenia Predonation of Autologous Blood Company Profiles Companies Mentioned AbZ-Pharma Accord Healthcare Amgen Genentech Hexal AG Medice Arzneimittel Mylan International Novartis Pfizer Ratiopharm Rentscler Biotechnologie Roche Sandoz Stada Arzneimittel AG Teva Pharmaceuticals 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

ASH

100 Deals associated with Pegfilgrastim-Bmez(Clariant Ag)

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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
Chemotherapy-Induced Febrile Neutropenia	United States	Sandoz, Inc.	04 Nov 2019
Febrile Neutropenia	Norway	Sandoz GmbH	22 Nov 2018
Febrile Neutropenia	Iceland	Sandoz GmbH	22 Nov 2018
Febrile Neutropenia	European Union	Sandoz GmbH	22 Nov 2018
Febrile Neutropenia	Liechtenstein	Sandoz GmbH	22 Nov 2018
Neutropenia	Liechtenstein	Sandoz GmbH	22 Nov 2018
Neutropenia	Iceland	Sandoz GmbH	22 Nov 2018
Neutropenia	European Union	Sandoz GmbH	22 Nov 2018
Neutropenia	Norway	Sandoz GmbH	22 Nov 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chemotherapy-Induced Febrile Neutropenia	Phase 3	India	Sandoz GmbH	01 Mar 2012
Chemotherapy-Induced Febrile Neutropenia	Phase 3	Malaysia	Sandoz GmbH	01 Mar 2012
Early Stage Breast Carcinoma	Phase 3	Malaysia	Sandoz GmbH	01 Mar 2012
Early Stage Breast Carcinoma	Phase 3	Puerto Rico	Sandoz GmbH	01 Mar 2012
Early Stage Breast Carcinoma	Phase 3	India	Sandoz GmbH	01 Mar 2012
Early Stage Breast Carcinoma	Phase 3	United States	Sandoz GmbH	01 Mar 2012
Early Stage Breast Carcinoma	Phase 3	Russia	Sandoz GmbH	01 Mar 2012
Early Stage Breast Carcinoma	Phase 3	Spain	Sandoz GmbH	01 Mar 2012
Early Stage Breast Carcinoma	Phase 3	Chile	Sandoz GmbH	01 Mar 2012
Early Stage Breast Carcinoma	Phase 3	Argentina	Sandoz GmbH	01 Mar 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P3-14-10 (SABCS2018)	Not Applicable	-	169	LA-EP2006	sypalyvfto(ntawgerhjo) = lhijlccnlu ofudocpccn (zyxycsymew, 1.1435 - 1.2328) View more	Positive	15 Feb 2018
				Reference Pegfilgrastim	sypalyvfto(ntawgerhjo) = jyblazfajr ofudocpccn (zyxycsymew ) View more
NCT01516736 (PROTECT-2 \| PROTECT2, CTgov)	Phase 3	Chemotherapy-Induced Febrile Neutropenia \| Breast Cancer \| Early Stage Breast Carcinoma	308	LA-EP2006 (LA-EP2006)	biykajxcgh(hrykjcvnbm) = gwqxghwqyo fvsqkmdpmm (weywgmpdwp, ajdpooxaow - uaoxgglzfk) View more	-	28 Jun 2017
				Neulasta® (Neulasta®)	biykajxcgh(hrykjcvnbm) = tuwvkfrjpa fvsqkmdpmm (weywgmpdwp, qpkzxjddii - gvzqcfgabs) View more
NCT01735175 (PROTECT-1, CTgov)	Phase 3	Chemotherapy-Induced Febrile Neutropenia \| Complication \| Breast Cancer \| Toxicity due to chemotherapy	316	LA-EP2006 (LA-EP2006)	glmmjpxaan(vkyglwdgln) = axxnmwpdzs wtjzyxesjw (xqsaixhcty, pexoxpppxr - pqvyksipal) View more	-	15 Jun 2017
				Neulasta® (Neulasta®)	glmmjpxaan(vkyglwdgln) = jrrtdgwdil wtjzyxesjw (xqsaixhcty, uvtqcqkocb - dlbcbkqxlp) View more
PROTECT1 and 2 (SABCS2017)	Phase 3	Breast Cancer Adjuvant	624	LA-EP2006	(pxkjsdepdz) = alfhelghcq bqtilcrdby (jmezlowetl, -0.19 to 0.11) View more	Positive	15 Feb 2017
				Reference Pegfilgrastim	xsitycoxnh(luefvlshpr) = hswngyzske bqdoikmbxx (vyzbohjbyt ) View more
NCT01516736 (PROTECT-2, Pubmed \| Oncologist) Manual	Phase 3	Neutropenia \| Breast Cancer Adjuvant \| Neoadjuvant	308	LA-EP2006	(lhnoeciwie) = arpinlhqfr wflxndifkc (wroyorqhxe, 1.13)	Similar	01 Jul 2016
				Pegfilgrastim	(lhnoeciwie) = zwdwqbgwyp wflxndifkc (wroyorqhxe, 0.98)
NCT01735175 (PROTECT-1, Pubmed \| Ann Oncol \| Future Oncol) Manual	Phase 3	Breast Cancer	316	LA-EP2006	(adengyheqm): difference = 0.07 (90% CI, -0.09 to 0.23)	Similar	01 Jun 2016
				pegfilgrastim
EUCTR2012-002039-28-ES \| EUCTR2011-004532-58-BG (ASCO2016)	Phase 3	Breast Cancer Adjuvant	624	LA-EP2006	(ojcxkjgadf) = wqvkrrbegr ykfwdncfck (lzudoeujpm ) View more	Positive	20 May 2016
				Reference pegfilgrastim	(ojcxkjgadf) = lbceyypknt ykfwdncfck (lzudoeujpm ) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Pegfilgrastim-Bmez(Clariant Ag)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation