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

NCT04022239

/ RecruitingPhase 1/2IIT

Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis

This phase I/II trial studies the side effects and best dose of bendamustine when given with or without cyclophosphamide in preventing graft versus host disease (GVHD) in patients undergoing stem cell transplant. Drugs used in chemotherapy, such as bendamustine and cyclophosphamide, 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 chemotherapy and total body irradiation before or after a stem cell transplant helps kills cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Sometimes, the transplanted cells from a donor can attack the body's normal cells called GVHD. Giving tacrolimus, mycophenolate mofetil, and filgrastim after the transplant may stop this from happening.

Start Date13 Mar 2020

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT03856216

/ RecruitingPhase 2IIT

Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation

The goal of this phase II clinical study is to learn about the safety of inotuzumab ozogamicin when given with fludarabine, with or without bendamustine, melphalan, and rituximab before and after a stem cell transplant. Researchers also want to learn if inotuzumab ozogamicin when given after a stem cell transplant can help control leukemia and lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab attaches to CD22-positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving chemotherapy before a bone marrow or peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor attack the body's normal cells (called graft-versus-host disease). Giving tacrolimus and filgrastim before or after the transplant may stop this from happening. Fludarabine, bendamustine, melphalan, and rituximab are commonly given before stem cell transplants. Giving inotuzumab ozogamicin with chemotherapy may work better in treating patients with leukemia or lymphoma undergoing stem cell transplantation.

Start Date28 Oct 2019

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

100 Clinical Results associated with Filgrastim-SNDZ(Sandoz International Gmbh)

100 Translational Medicine associated with Filgrastim-SNDZ(Sandoz International Gmbh)

100 Patents (Medical) associated with Filgrastim-SNDZ(Sandoz International Gmbh)

Literatures (Medical) associated with Filgrastim-SNDZ(Sandoz International Gmbh)

01 Apr 2024·Critical reviews in oncology/hematology

Filgrastim biosimilar (EP2006): A review of 15 years’ post-approval evidence

Review

Author: Harbeck, Nadia ; Aapro, Matti ; Brueckmann, Ines ; Gascón, Pere ; Rapoport, Bernardo L ; Howe, Sebastian ; Anderson, Ronald

Filgrastim is approved for several indications, including reduction of the incidence and duration of chemotherapy-induced neutropenia and for stem cell mobilization. The filgrastim biosimilar, EP2006, has been available in Europe since 2009, and in the United States since 2015. In this time, preclinical and clinical data used to support the approval of EP2006 have been published. These data established the biosimilarity of EP2006 to reference filgrastim in terms of structure, pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity. Additional real-world evidence studies have also demonstrated equivalent efficacy and safety of EP2006 compared with reference filgrastim, both in the reduction of neutropenia and in stem cell mobilization in clinical practice. This review summarizes these preclinical, clinical, and real-world data, as well as the available cost-effectiveness data, for EP2006 since its approval 15 years ago.

01 Jan 2024·Journal of managed care & specialty pharmacy

Filgrastim and infliximab biosimilar uptake in Medicare Advantage compared with Traditional Medicare, 2016-2019

Article

Author: Anderson, Gerard ; Socal, Mariana ; Anderson, Kelly E ; Liu, Angela ; Xuan, Andrew

BACKGROUND:

Medicare Advantage (MA) and Traditional Medicare face different financing structures and incentives and may implement different strategies to encourage biosimilar uptake. Strategies used by health insurers can influence biosimilar uptake, which can in turn promote savings to insurers and patients.

OBJECTIVE:

To compare filgrastim and infliximab biosimilar uptake between MA and Traditional Medicare from 2016 to 2019 and examine biosimilar uptake by different MA carriers and plan types (Health Maintenance Organization [HMO] or Preferred Provider Organization).

METHODS:

We use a 2016-2019 nationally representative random 20% sample of the carrier (physician) and outpatient paid claims for Traditional Medicare data and final-action carrier and outpatient records for MA data. We compare quarterly biosimilar uptake from 2016 to 2019 for the first 2 drugs with biosimilar competition: (1) filgrastim, (Neupogen, originator), and biosimilars tbo-filgrastim (GRANIX) and filgrastim-sndz (ZARXIO), and (2) infliximab (Remicade, originator), and biosimilars infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis).

RESULTS:

From their introduction, there was consistently greater uptake of filgrastim and infliximab biosimilars in MA compared with Traditional Medicare. By Q4 2019, filgrastim biosimilar uptake was 7.6 percentage points higher in MA (80.3%) than Traditional Medicare (72.7%). By Q4 2019, infliximab biosimilar uptake was 28.7% and 15.4% in MA and Traditional Medicare, respectively. Kaiser HMO plans were primarily responsible for the higher uptake of biosimilars in MA; in Q4 2019, filgrastim and infliximab biosimilar uptake was 98.8% and 78.8%, respectively.

CONCLUSIONS:

Our findings suggest that filgrastim and infliximab biosimilar uptake is greater in MA compared with Traditional Medicare, which is driven in part by particularly high uptake of biosimilars in MA Kaiser HMO plans. This highlights the need for future work to examine specific strategies and levers employed by MA Kaiser HMO plans and other insurers to increase biosimilar uptake, which can lead to cost savings for physician-administered drugs.

31 Dec 2023·Journal of medical economics

Cost-efficiency analysis of conversion to biosimilar filgrastim for supportive cancer care and resultant expanded access analysis to supportive care and early-stage HER2+ breast cancer treatment in Saudi Arabia: simulation study

Article

Author: Yousef, Consuela Cheriece ; Al-Foheidi, Meteb ; AlAbdalkarim, Hana ; Alshamrani, Majed ; AlJedai, Ahmed ; Naeem, Anjum ; Khan, Mansoor Ahmed ; Almodaimegh, Hind ; Abraham, Ivo

AIMS:

This study estimated, for Saudi Arabia, the cost-efficiency of converting patients from reference Neupogen and Neulastim to one of two filgrastim biosimilars (Nivestim, Zarzio); the budget-neutral expanded access to supportive care with biosimilar filgrastim and therapeutic care to ado-trastuzumab emtansine thus afforded; and the number-needed-to-convert (NNC) to provide supportive or therapeutic treatment to one patient.

MATERIALS AND METHODS:

Replicating prior studies, we modeled the cost-efficiencies gained from converting varying proportions of a hypothetical panel of 4,000 patients undergoing six cycles of cancer treatment from Neupogen or Neulastim to one of the two biosimilar G-CSF formulations, using national cost inputs. Cost-savings in USD were used to estimate the additional doses of biosimilar G-CSF and expanded access to ado-trastuzumab emtansine on a budget-neutral basis, and NNC to purchase one additional dose of supportive or therapeutic treatment.

RESULTS:

Savings from conversion from reference to a biosimilar filgrastim were $3,086,400 (Nivestim) and $3,460,800 (Zarzio). With reference pegfilgrastim, savings from conversion were $11,712,240 (Nivestim) and $12,086,640 (Zarzio). Biosimilar conversion from reference to biosimilar filgrastim enabled expanded access to ado-trastuzumab emtansine ranging from 61 patients (5 days, Nivestim) to 191 patients (14 days, Zarzio). For supportive care, biosimilar conversion enabled expanded access ranging from 8,244 patients (5 days, Nivestim) to 25,882 patients (14 days, Zarzio). For biosimilar conversion from daily filgrastim, the NNC for treatment with ado-trastuzumab emtansine decreased as days of injections increased [5 days: 395 (Nivestim), 352 (Zarzio); 14 days: 141(Nivestim), 126 (Zarzio)]. Alternately, for biosimilar conversion from single-injection pegfilgrastim to daily biosimilar filgrastim, the NNC for treatment with ado-trastuzumab emtansine rose as days of injections increased, being highest under the 14-day scenario (146, Nivestim; 130, Zarzio).

CONCLUSION:

This simulation study demonstrated significant potential cost-savings from biosimilar conversion. These savings provide budget-neutral increased access to supportive and therapeutic cancer care.

News (Medical) associated with Filgrastim-SNDZ(Sandoz International Gmbh)

30 Apr 2025

·pipelinereview.com

Sandoz enters global collaboration license agreement with Henlius to commercialize leading oncology therapy, ipilimumab, in multiple indications

BASEL, Switzerland I April 29, 2025 I Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, announced today that it has signed a global collaboration agreement with Shanghai Henlius Biotech, Inc. (Henlius, HKEX:02696) to commercialize a biosimilar of leading oncology therapy, ipilimumab. The agreement is milestone-based for a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, and will target net reference-medicine sales of USD 2.5 billion[1]. Under the terms of the agreement, Sandoz has exclusive commercial rights for a biosimilar of ipilimumab in Australia, Canada, Europe, Japan and the US. The core sequence patent for ipilimumab expired in March 2025 in the US and will expire no later than February 2026 in the EU. Richard Saynor, CEO of Sandoz, said: “The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater.[3] This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems.” The reference medicine, ipilimumab, is a monoclonal (CTLA-4) antibody-blocking medication, which is used alone or with other medicines to treat certain types of colorectal cancer, esophageal cancer, hepatocellular carcinoma (a type of liver cancer), malignant pleural mesothelioma, melanoma, non-small cell lung cancer, and renal cell carcinoma (a type of kidney cancer).[4,5,6] Henlius is developing its own proposed biosimilar of ipilimumab in an integrated Phase I/III trial in the unresectable hepatocellular carcinoma setting, targeting 656 patients to be enrolled (NCT06841185). Sandoz is developing its own proposed biosimilar of nivolumab in an integrated Phase I/III trial in the advanced melanoma setting, targeting 720 patients to be enrolled (NCT06587451). The reference medicine, nivolumab, (Opdivo®**) is a monoclonal (PD-1) antibody-blocking medication, which is used alone or with other medicines to treat more than 10 different cancer types. In combination with ipilimumab, nivolumab is indicated for the treatment of melanoma, malignant pleural mesothelioma, renal cell carcinoma, certain types of colorectal cancer, esophageal cancer, non-small cell lung cancer and hepatocellular carcinoma.[7,8] Sandoz is the leading biosimilar provider globally and has recently moved up to third position in the US, with a strategic ambition to occupy the leading position in that market.[9] The Company’s industry-leading biosimilars pipeline comprises 28 molecules, complemented by around 450 generic pipeline medicines to support its goal of sustainable and broadly-based long-term growth. The marketed biosimilar oncology portfolio includes Rixathon®, Zarzio®, Ziextenzo®, and Binocrit®. This year, Sandoz expects to launch its biosimilars Wyost®/Jubbonti® (denosumab) in the US in the second quarter and in Europe in the fourth quarter. * Yervoy® is a registered trademark of Bristol-Myers Squibb (US) ** Opdivo® is a registered trademark of Bristol-Myers Squibb (US) REFERENCES 1. Loss-of-exclusivity (LoE) dates based on IP databases; originator-sales data at LoE-1 from internal analysis and Evaluate Pharma [November 2024] 2. Decisions Resource Group (DRG) database of total treated population with Yervoy® (G7 markets) [accessed April 2025] 3. Cancer Today [accessed March 2025] 4. Yervoy® US Prescribing Information [accessed March 2025] 5. Yervoy® EMEA Summary of Product Characteristics [accessed March 2025] 6. Definition of Yervoy ® – NCI Dictionary of Cancer Terms – NCI [accessed March 2025] 7. Opdivo® US: Prescribing Information [accessed March 2025] 8. Opdivo® EMEA Summary of Product Characteristics [accessed March 2025] 9. IQVIA [download February 2025] ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. SOURCE: Sandoz

License out/inDrug ApprovalBiosimilar

29 Apr 2025

·www.globenewswire.com

Sandoz enters global collaboration license agreement with Henlius to commercialize leading oncology therapy, ipilimumab, in multiple indications

MEDIA RELEASE Agreement offers rights to commercialize proposed biosimilar of Yervoy®* for treatment of variety of cancer types, targeting net reference medicine sales of USD 2.5 billion[1]Henlius to develop and manufacture biosimilar, with Sandoz to register and commercialize after expiry of relevant patents across global marketsCombination therapy of ipilimumab and nivolumab used in 95% of eligible patients[2]; ipilimumab highly complementary to proposed Sandoz nivolumab biosimilarPotential to address considerable unmet medical needs and increase worldwide access; reinforces Sandoz commitment to expand patient access and drive sustainable savings for healthcare systems Basel, April 29, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, announced today that it has signed a global collaboration agreement with Shanghai Henlius Biotech, Inc. (Henlius, HKEX:02696) to commercialize a biosimilar of leading oncology therapy, ipilimumab. The agreement is milestone-based for a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, and will target net reference-medicine sales of USD 2.5 billion[1]. Under the terms of the agreement, Sandoz has exclusive commercial rights for a biosimilar of ipilimumab in Australia, Canada, Europe, Japan and the US. The core sequence patent for ipilimumab expired in March 2025 in the US and will expire no later than February 2026 in the EU. Richard Saynor, CEO of Sandoz, said: “The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater.[3] This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems.” The reference medicine, ipilimumab, is a monoclonal (CTLA-4) antibody-blocking medication, which is used alone or with other medicines to treat certain types of colorectal cancer, esophageal cancer, hepatocellular carcinoma (a type of liver cancer), malignant pleural mesothelioma, melanoma, non-small cell lung cancer, and renal cell carcinoma (a type of kidney cancer).[4,5,6] Henlius is developing its own proposed biosimilar of ipilimumab in an integrated Phase I/III trial in the unresectable hepatocellular carcinoma setting, targeting 656 patients to be enrolled (NCT06841185). Sandoz is developing its own proposed biosimilar of nivolumab in an integrated Phase I/III trial in the advanced melanoma setting, targeting 720 patients to be enrolled (NCT06587451). The reference medicine, nivolumab, (Opdivo®**) is a monoclonal (PD-1) antibody-blocking medication, which is used alone or with other medicines to treat more than 10 different cancer types. In combination with ipilimumab, nivolumab is indicated for the treatment of melanoma, malignant pleural mesothelioma, renal cell carcinoma, certain types of colorectal cancer, esophageal cancer, non-small cell lung cancer and hepatocellular carcinoma.[7,8] Sandoz is the leading biosimilar provider globally and has recently moved up to third position in the US, with a strategic ambition to occupy the leading position in that market.[9] The Company’s industry-leading biosimilars pipeline comprises 28 molecules, complemented by around 450 generic pipeline medicines to support its goal of sustainable and broadly-based long-term growth. The marketed biosimilar oncology portfolio includes Rixathon®, Zarzio®, Ziextenzo®, and Binocrit®. This year, Sandoz expects to launch its biosimilars Wyost®/Jubbonti® (denosumab) in the US in the second quarter and in Europe in the fourth quarter. * Yervoy® is a registered trademark of Bristol-Myers Squibb (US)** Opdivo® is a registered trademark of Bristol-Myers Squibb (US) DISCLAIMERThis Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law. REFERENCES1. Loss-of-exclusivity (LoE) dates based on IP databases; originator-sales data at LoE-1 from internal analysis and Evaluate Pharma [November 2024]2. Decisions Resource Group (DRG) database of total treated population with Yervoy® (G7 markets) [accessed April 2025]3. Cancer Today [accessed March 2025]4. Yervoy® US Prescribing Information [accessed March 2025]5. Yervoy® EMEA Summary of Product Characteristics [accessed March 2025]6. Definition of Yervoy® - NCI Dictionary of Cancer Terms - NCI [accessed March 2025]7. Opdivo® US: Prescribing Information [accessed March 2025]8. Opdivo® EMEA Summary of Product Characteristics [accessed March 2025]9. IQVIA [download February 2025] ABOUT SANDOZSandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. CONTACTS Global Media RelationsInvestor RelationsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comAlex Kalomparis+41 79 279 0285Craig Marks+44 7818 942 383Joerg E. Allgaeuer+49 171 838 4838Rupreet Sandhu+41 79 410 5472 Attachment Media release_collaboration license agreement

License out/in

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

100 Deals associated with Filgrastim-SNDZ(Sandoz International Gmbh)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L03AA02	DB00099

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Stem cell mobilisation	United States	Sandoz, Inc.	06 Mar 2015
Chemotherapy-Induced Febrile Neutropenia	European Union	Sandoz GmbH	06 Feb 2009
Chemotherapy-Induced Febrile Neutropenia	Iceland	Sandoz GmbH	06 Feb 2009
Chemotherapy-Induced Febrile Neutropenia	Liechtenstein	Sandoz GmbH	06 Feb 2009
Chemotherapy-Induced Febrile Neutropenia	Norway	Sandoz GmbH	06 Feb 2009
Cyclic Neutropenia	European Union	Sandoz GmbH	06 Feb 2009
Cyclic Neutropenia	Iceland	Sandoz GmbH	06 Feb 2009
Cyclic Neutropenia	Liechtenstein	Sandoz GmbH	06 Feb 2009
Cyclic Neutropenia	Norway	Sandoz GmbH	06 Feb 2009
Febrile Neutropenia	European Union	Hexal AG	06 Feb 2009
Febrile Neutropenia	Iceland	Hexal AG	06 Feb 2009
Febrile Neutropenia	Liechtenstein	Hexal AG	06 Feb 2009
Febrile Neutropenia	Norway	Hexal AG	06 Feb 2009
Neutropenia	European Union	Sandoz GmbH	06 Feb 2009
Neutropenia	European Union	Hexal AG	06 Feb 2009
Neutropenia	Iceland	Sandoz GmbH	06 Feb 2009
Neutropenia	Iceland	Hexal AG	06 Feb 2009
Neutropenia	Liechtenstein	Sandoz GmbH	06 Feb 2009
Neutropenia	Liechtenstein	Hexal AG	06 Feb 2009
Neutropenia	Norway	Sandoz GmbH	06 Feb 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 3	Czechia	Sandoz Group AG	01 Dec 2011
Breast Cancer	Phase 3	Czechia	Sandoz International GmbH	01 Dec 2011
Breast Cancer	Phase 3	Hungary	Sandoz International GmbH	01 Dec 2011
Breast Cancer	Phase 3	Hungary	Sandoz Group AG	01 Dec 2011
Breast Cancer	Phase 3	Latvia	Sandoz Group AG	01 Dec 2011
Breast Cancer	Phase 3	Latvia	Sandoz International GmbH	01 Dec 2011
Breast Cancer	Phase 3	Russia	Sandoz Group AG	01 Dec 2011
Breast Cancer	Phase 3	Russia	Sandoz International GmbH	01 Dec 2011
Breast Cancer	Phase 3	Slovakia	Sandoz International GmbH	01 Dec 2011
Breast Cancer	Phase 3	Slovakia	Sandoz Group AG	01 Dec 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03417284 (CTgov)	Phase 1/2	Relapse multiple myeloma \| Multiple Myeloma	62	melphalan+Filgrastim-sndz+Melphalan Hydrochloride (Group1_Dose 1 200mgm2)	pmshlircab = axematnwnf wsxrtdkffp (eqyzacwcjb, qbbbviuuku - kbaawettfd) View more	-	01 May 2025
				melphalan+Filgrastim-sndz+Melphalan Hydrochloride (Group 1_Dose 2 225mgm2)	pmshlircab = wjbyrojguv wsxrtdkffp (eqyzacwcjb, wqryaxkkfx - pvcqmgoptn) View more
P179 (EBMT2021)	Not Applicable	Stem cell mobilisation CD34+	140	Zarzio	zrwihourfb(apovjalruk) = fqmowumvfn wfwetoahuj (plamrtgrpi )	-	14 Mar 2021
				Neupogen	zrwihourfb(apovjalruk) = cegzzjisrn wfwetoahuj (plamrtgrpi )
Tandem Meetings ASTCT and CIBMTR2019	Not Applicable	-	186	Filgrastim	zioyzcwqoo(pydxrumzbd) = xybdljsjlm axtydckydy (vvvtyrhupr ) View more	Positive	01 Mar 2019
				Filgrastim-SNDZ	zioyzcwqoo(pydxrumzbd) = cwxugubnex axtydckydy (vvvtyrhupr ) View more
PIONEER and MONITOR-GCSF (ASCO2018)	Phase 3	Breast Cancer	-	Sandoz biosimilar filgrastim	ilwvybwcaw(bnzqnrogzf) = PIONEER: 673, MONITOR-GCSF: 7 sqqkfrzjpj (dzyvofbuqt ) View more	Positive	01 Jun 2018
				Reference filgrastim
Abstract P4-12-07 (SABCS2018)	Not Applicable	Breast Cancer HER2-negative	-	ZARXIO®	gxianzpkgb(zesyswfvvu) = npcjfvpgvx alglotgxad (dimfibfbkk ) View more	-	15 Feb 2018
				NEUPOGEN®	srrfflfnvq(fvegtlahyz) = ktsignbhic tmbfkcdorx (dlbhyzwwuj )
MONITOR-GCSF (ICML2017)	Not Applicable	Diffuse Large B-Cell Lymphoma	245	Biosimilar filgrastim (Zarzio/Zarxio/EP2006)	bwhxjyaham(asdlqdlpfn) = 0.8% ( n = 2) bbvmysvysl (jgtcljspik ) View more	Positive	07 Jun 2017
NCT01519700 (ASCO2017)	Phase 3	Breast Cancer Adjuvant	218	Reference filgrastim	pueszmfsrh(iyfxrkfqtm) = xhyurameuy eluxmqlmml (ivjqckudvx ) View more	Positive	30 May 2017
				Alternating treatment with reference and biosimilar	pueszmfsrh(iyfxrkfqtm) = uuueywdsik eluxmqlmml (ivjqckudvx ) View more
NCT01519700 (PIONEER, CTgov)	Phase 3	Neutropenia \| Breast Cancer	218	EP2006	qswnkczaxm = uswykhezur auwvcepdsb (evkfyfszpj, uwewexkzau - auummbhuwq) View more	-	07 Apr 2015

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