Here is a list of Pfizer's biosimilar products:
Proper Name Proprietary Name Reference Approval
Infliximab-dyyb Inflectra REMICADE (infliximab) 2016
Filgrastim-aafi Nivestym NEUPOGEN (filgrastim) 2018
Epoetin alfa-epbx Retacrit EPOGEN/PROCRIT (epoetin alfa) 2018
Rituximab-pvvr Ruxience RITUXAN (rituximab) 2019
Trastuzumab-qyyp Trazimera HERCEPTIN (trastuzumab) 2019
Bevacizumab-bvzr Zirabev AVASTIN (bevacizumab) 2019
Adalimumab-afzb Abrilada HUMIRA (adalimumab) 2019
Pegfilgrastim-apgf Nyvepria NEULASTA (pegfilgrastim) 2020
As of Feb 2, 2024, the competitors of Pfrizer's first biosimilar product, INFLECTRA is summarized as follows:
Reference Product: Infliximab (Remicade)
Product Proper Name Proprietary Applicant BLA Strength Presentation Route
Reference Infliximab Remicade Centocor Inc. 103772 100 mg, single dose vial, i.v.
Biosimilar Infiximab-AXXQ Avsola Amgen Inc. 761086 100 mg, single dose vial, i.v.
Biosimilar Infiximab-DYYB Inflectra Celltrion Inc. 12554 100 mg, single dose vial, i.v.
Biosimilar Infiximab-ABDA Renflexis Samsung Bioepis 761054 100 mg, single dose vial, i.v.
Biosimilar Infliximab-QBTX Ixifi Pfizer Inc. 761072 100 mg, single dose vial, i.v.
The approval date for Avsola is 12/06/2019, Inflectra 04/05/2016, Renflexis Renflexis 04/21/2017 and Ixifi 12/13/2017.
Reference Product: Infliximab-DYYB (Zymfentra)
Reference Infliximab-DYYB Zymfentra Celltrion, Inc. 761358 120 mg/ml pre-filled syringe
autoinjector, subcutaneous
approval date: 10/20/2023.
As of Feb 2, 2024, the competitors of Pfrizer's biosimilar product approved in 2020, NEUPOGEN is summarized as follows:
Reference Product: Filgrastim (NEUPOGEN) ; Approval: 1991
Product Proper Name Proprietary Applicant BLA Strength Presentation
Reference Filgrastim NEUPOGEN Amgen 103353 300mcg/1ml vial
Reference Filgrastim NEUPOGEN Amgen 103353 480mcg/1.6ml vial
Reference Filgrastim NEUPOGEN Amgen 103353 300mcg/0.5ml syringe
Reference Filgrastim NEUPOGEN Amgen 103353 400mcg/0.8ml syringe
Biosimilar Filgrastim-aafi NIVESTYM Pfizer 761080 300mcg/1ml vial (i.v. & s.c.)
Biosimilar Filgrastim-aafi NIVESTYM Pfizer 761080 480mcg/1.6ml vial (i.v. & s.c.)
Biosimilar Filgrastim-aafi NIVESTYM Pfizer 761080 300mcg/0.5ml syringe (s.c.)
Biosimilar Filgrastim-aafi NIVESTYM Pfizer 761080 400mcg/0.5ml syringe (s.c.)
Biosimilar Filgrastim-ayow RELEUKO Kashiv Bios. 761082 300mcg/1ml vial (i.v. & s.c.)
Biosimilar Filgrastim-ayow RELEUKO Kashiv Bios. 761082 480mcg/1.6ml vial (i.v. & s.c.)
Biosimilar Filgrastim-ayow RELEUKO Kashiv Bios. 761082 300mcg/0.5ml syringe (s.c.)
Biosimilar Filgrastim-ayow RELEUKO Kashiv Bios. 761082 400mcg/0.5ml syringe (s.c.)
Biosimilar Figrastim-sndz ZARXIO Sandoz Inc. 125553 300mcg/1ml vial (i.v. & s.c.)
Biosimilar Figrastim-sndz ZARXIO Sandoz Inc. 125553 480mcg/1ml vial (i.v. & s.c.)
In addition to these Biosimilars, NEUPOGEN also faces a limited competition from GRANIX (tbo-filgrastim) and NEULASTA/NEULASTA ONPRO (pegfilgrastim) together with their biosimilars. NEUPOGEN, GRANIX and NEULASTAs' indications are summarized as follows:
INDICATIONS ANDA USE - NEUPOGEN, GRANIX and NEULASTA
NEUPOGEN is a leukocyte growth factor indicated to
• Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever
• Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
• Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)
• Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
• Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia
• Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)
GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated in adult and pediatric patients 1 month and older for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
Neulasta is a leukocyte growth factor indicated to:
• Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
• Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
MISTAKES MIGHT HAPPEN DURING THE PREPARATION OF THIS ARTICLE. FOR ACCURACY AND DETAILS, PLEASE CHECK WITH FDA PURPLEBOOK AND RELATED INFORMATION SOURCES.
Reference
1. https://biosimilars.pfizerpro.com/
