Ozmosi | PF-05280586 Drug Profile

Product Description

PF-05280586 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Rituxan/MabThera. Rituxan/MabThera is indicated for the treatment of patients with certain types of CD20-positive non-Hodgkin lymphoma; CD20-positive chronic lymphocytic leukemia; rheumatoid arthritis; granulomatosis with polyangiitis and microscopic polyangiitis; and other region-specific indications. (Sourced from: https://www.pfizer.com/news/press-release/press-release-detail/pfizer_presents_positive_26_week_data_for_pf_05280586_a_potential_biosimilar_to_rituximab_at_the_american_society_of_hematology_annual_meeting)

Mechanisms of Action: TNF Inhibitor

Novel Mechanism: No

Modality: Antibody

Route of Administration: Intravenous

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Pfizer
Company Location: Eastern America
Company Founding Year: 1849
Additional Commercial Interests: None

Clinical Description

Countries in Clinic:

Active Clinical Trial Count:

Recent & Upcoming Milestones

Highest Development Phases

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Latest Trial Update Date	Data Updated
ACTRN12622000306718p	2006-7041-83/hah	N/A	Not yet recruiting	Intestinal Diseases\|Dental Caries	2022-02-28
NCT01643928	REFLECTIONS B328-04	N/A	Completed	Arthritis, Rheumatoid	2016-03-14	2019-03-19	Primary Completion Date\|Start Date
NCT05052528	UCDCC#299	P1	Recruiting	Diffuse Large B-Cell Lymphoma	2025-05-15	2024-05-14
NCT02960646	NCI-2016-01915	P1	Completed	Acute Myeloid Leukemia\|Leukemia, Plasma Cell\|Preleukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Lymphocytic Chronic B-Cell Leukemia\|Lymphoma, Non-Hodgkin\|Lymphoma, B-Cell\|Acute Monocytic Leukemia\|Chronic Myelomonocytic Leukemia\|Anemia, Aplastic\|Blast Crisis\|Myelodysplastic Syndrome\|Chronic Lymphoid Leukemia\|Juvenile Myelomonocytic Leukemia,\|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma\|Acute Lymphoid Leukemia\|Acute Myelomonocytic Leukemia\|Multiple Myeloma\|Myeloproliferative Disorders\|Chronic Myeloid Leukemia\|Myelogenous, Chronic, BCR-ABL Positive Leukemia	2023-02-13	2023-02-18	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status
NCT03432741	MC1689	P1	Terminated	Mycosis Fungoides\|Lymphoma, Non-Hodgkin\|B-Cell Marginal Zone Lymphoma\|Breast Cancer\|T-Cell Cutaneous Lymphoma\|Adenocarcinoma	2022-08-26	2025-05-28	Primary Completion Date\|Primary Endpoints\|Treatments
NCT01619761	NCI-2012-02071	P1	Unknown status	Lymphoma, Non-Hodgkin\|Chronic Myeloid Leukemia\|Acute Lymphoid Leukemia\|Myelodysplastic Syndrome\|Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Lymphoma, B-Cell\|Leukemia, Plasma Cell\|Biphenotypic Acute Leukemia\|Myeloid, Accelerated Leukemia\|Acute Myeloid Leukemia\|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma\|Lymphocytic Chronic B-Cell Leukemia\|Myelogenous, Chronic, BCR-ABL Positive Leukemia\|Chronic Lymphoid Leukemia\|Multiple Myeloma\|Preleukemia	2021-11-01	2022-02-02	Primary Endpoints\|Treatments\|Trial Status
NCT02779283	IRB00011766	P1	Completed	Acute Lymphoid Leukemia\|Acute Myeloid Leukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma	2018-04-19	2025-02-07	Primary Endpoints\|Treatments
NCT02727803	NCI-2016-00584	P2	Recruiting	Myeloproliferative Disorders\|Myelodysplastic Syndrome\|Lymphoma, B-Cell\|Acute Myelomonocytic Leukemia\|Preleukemia\|Multiple Myeloma\|Anemia, Refractory, with Excess of Blasts\|Chronic Lymphoid Leukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Myelodysplastic-Myeloproliferative Diseases\|Acute Myeloid Leukemia\|Biphenotypic Acute Leukemia\|Chronic Myeloid Leukemia\|Chronic Myelomonocytic Leukemia\|Acute Monocytic Leukemia\|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma\|B-Cell Leukemia\|Leukemia, Plasma Cell\|Acute Lymphoid Leukemia\|Juvenile Myelomonocytic Leukemia,\|Myeloid, Accelerated Leukemia\|Myelogenous, Chronic, BCR-ABL Positive Leukemia\|Lymphoma, Non-Hodgkin	2027-05-31	2025-05-10	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT06834373	MC230813	P2	Recruiting	Diffuse Large B-Cell Lymphoma\|Inflammation\|T-Cell Cutaneous Lymphoma\|Follicular Lymphoma\|Lymphoma, Non-Hodgkin	2027-03-03	2025-04-05	Primary Endpoints\|Start Date\|Treatments\|Trial Status
NCT03096782	NCI-2018-01236	P2	Completed	Acute Monocytic Leukemia\|Biphenotypic Acute Leukemia\|Chronic Myeloid Leukemia\|Myeloid, Accelerated Leukemia\|Juvenile Myelomonocytic Leukemia,\|Histiocytosis, Langerhans-Cell\|Acute Lymphoid Leukemia\|Lymphocytic Chronic B-Cell Leukemia\|Preleukemia\|Lymphoma, Non-Hodgkin\|Acute Myeloid Leukemia\|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma\|Myelodysplastic Syndrome\|Hodgkin Lymphoma\|Chronic Myelomonocytic Leukemia\|Acute Myelomonocytic Leukemia\|Chronic Lymphoid Leukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Lymphoma, B-Cell\|Anemia, Refractory, with Excess of Blasts\|Myelogenous, Chronic, BCR-ABL Positive Leukemia	2022-09-20	2023-06-30	Primary Endpoints
2012-003223-38	REFLECTIONS B328-04	P2	Completed	Arthritis, Rheumatoid	2016-03-14	2022-03-13	Treatments
2011-002896-40	2011-002896-40	P2	Completed	Arthritis, Rheumatoid	2014-05-07	2022-03-13	Treatments
NCT01526057	REFLECTIONS	P2	Completed	Arthritis, Rheumatoid	2013-08-13	2019-03-19	Treatments
NCT05457556	ASCT2031	P3	Active, not recruiting	Acute Lymphoid Leukemia\|Myelodysplastic Syndrome\|Acute Myeloid Leukemia\|Preleukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma	2026-06-30	2025-05-06	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status
NCT02003222	NCI-2013-02229	P3	Active, not recruiting	Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Acute Lymphoid Leukemia	2023-06-23	2025-02-07	Primary Endpoints\|Treatments
JapicCTI-152823	JapicCTI-152823	P3	Unknown	Follicular Lymphoma	2018-04-19
2014-000132-41	2014-000132-41	P3	Completed	Follicular Lymphoma	2018-04-19	2022-03-13	Treatments
NCT02213263	REFLECTIONS B328-06	P3	Completed	Follicular Lymphoma	2017-10-23	2019-03-20

Recent News Events

Date	Type	Title
01/01/2006	PubMed	Rituximab.
04/01/2022	PubMed	Analytical similarity as base for rituximab biosimilars in lymphoid malignancies in the clinic: a PF-05280586 case study.
07/01/2021	PubMed	Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar.
04/02/2020	News Article	Pfizer Receives European Approval for Oncology Biosimilar, RUXIENCE™ (rituximab)
01/31/2020	News Article	Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, RUXIENCE™ (rituximab)
07/23/2019	News Article	FDA Approves Pfizer's Biosimilar, RUXIENCE™ (rituximab-pvvr), for Certain Cancers and Autoimmune Conditions
01/29/2019	News Article	PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2018 RESULTS

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PF-05280586

Alternative Names: pf-05280586, pf05280586, pf 05280586 Clinical Status: Inactive Latest Update: 2026-03-04 Latest Update Note: Clinical Trial Update