Biosimilars

  • Biosimilars

    Riabni (rituximab-arrx)

    What is RIABNI? RIABNI is a prescription medicine used to treat adults with: Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines. Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide. Rheumatoid Arthritis (RA) Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA RIABNI is not indicated for the treatment of children. What should I tell my doctor before using RIABNI? Before you receive RIABNI, tell your doctor about all of your medical conditions, including if you: have had a severe reaction to RIABNI or another rituximab product. have a history of irregular heartbeat, heart problems, or chest pain. have…

  • Biosimilars

    Ruxience (rituximab-pvvr) for Inflammatory Diseases

    What is RUXIENCE and what is it used for? RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin’s Lymphoma (NHL): refractory or relapsed, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing, low-grade, CD20- positive, B-cell NHL as a single agent after first-line vincristine, cyclophosphamide, and prednisone chemotherapy. Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, vincristine, doxorubicin, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.…

  • Biosimilars

    Hadlima (adalimumab-bwwd) for Inflammatory Diseases

    What is HADLIMA? HADLIMA is a Tumor Necrosis Factor (TNF) blocker that is used: to reduce the signs and symptoms of: Moderate to severe Rheumatoid arthritis in adults: HADLIMA can be used alone, with methotrexate, or with certain other medicines. Moderate to severe polyarticular juvenile idiopathic arthritis: in children 4 years and older. HADLIMA can be used alone, with methotrexate, or with certain other medicines. Psoriatic arthritis in adults: HADLIMA can be used alone or with certain other medicines. Ankylosing spondylitis in adults. Moderate to severe Crohn’s disease: in adults when other treatments have not worked well enough. in adults, to help get moderate to severe ulcerative colitis under control…

  • Biosimilars

    Ziextenzo (pegfilgrastim-bmez) for Neutropenia

    What is ZIEXTENZO and what is it used for? ZIEXTENZO is a man-made form of G-CSF or granulocyte colony-stimulating factor. G-CSF stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection. ZIEXTENZO is 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. Who should not use ZIEXTENZO? Do not take ZIEXTENZO if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products. ZIEXTENZO should not be used for the mobilization of peripheral blood progenitor cells for hematopoietic stem…

  • Biosimilars

    Abrilada (adalimumab-afzb) for Inflammatory Diseases

    What is ABRILADA? ABRILADA is a tumor necrosis factor (TNF) blocker and is used: To reduce the signs and symptoms of: Moderate to severe rheumatoid arthritis in adults: ABRILADA can be used alone, with methotrexate, or with certain other medicines. Moderate to severe polyarticular juvenile idiopathic arthritis in children 4 years and older. ABRILADA can be used alone, with methotrexate, or with certain other medicines. Psoriatic arthritis in adults: ABRILADA can be used alone or with certain other medicines. Ankylosing spondylitis in adults. Moderate to severe Crohn’s disease: in adults when other treatments have not worked well enough. Moderate to severe Ulcerative colitis: in adults to help keep their ulcerative…

  • Biosimilars

    NYVEPRIA (pegfilgrastim-apgf) for Neutropenia

    What is NYVEPRIA and what is it used for? NYVEPRIA is a man-made form of G-CSF or granulocyte colony-stimulating factor. G-CSF stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection. NYVEPRIA is 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. Who should not use NYVEPRIA? Do not take NYVEPRIA if you have had a serious allergic reaction to pegfilgrastim products or filgrastim products. NYVEPRIA should not be used for the mobilization of peripheral blood progenitor cells for hematopoietic stem…

  • Biosimilars

    Hulio (adalimumab-fkjp) for Inflammatory Diseases

    What is HULIO and what is it used for? HULIO is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Rheumatoid Arthritis: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. Juvenile Idiopathic Arthritis: Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older. Psoriatic Arthritis: Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. Ankylosing Spondylitis: Reducing signs and symptoms in adult patients with active AS. Adult Crohn’s Disease:…

  • Biosimilars

    SEMGLEE (insulin glargine-yfgn)

    What is SEMGLEE? SEMGLEE is man-made insulin used to control high blood sugar in adults with diabetes mellitus. SEMGLEE should not be used to treat diabetic ketoacidosis. It is not known if SEMGLEE is safe to use in children less than 6 years of age with type 1 diabetes It is not known if SEMGLEE is safe to use in children with type 2 diabetes. Who should not use SEMGLEE? Do not use SEMGLEE if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to insulin glargine products or any of the ingredients in SEMGLEE. What should I tell my doctor before using SEMGLEE? Before using…

  • Biosimilars

    BYOOVIZ (ranibizumab-nuna) for Treatment of Retina

    What is BYOOVIZ and what is it used for? BYOOVIZ is a VEGF or vascular endothelial growth factor inhibitor and is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) Who should not use BYOOVIZ? If you have ocular or periocular infections If you have hypersensitivity reactions to BYOOVIZ or any of the ingredients present in this medicine What should I tell my doctor using BYOOVIZ? If you are pregnant or planning to become pregnant. If you are breastfeeding or planning to breastfeed. Dosage and Administration For ophthalmic intravitreal (in the eyes) injection only Neovascular…

  • Biosimilars

    Releuko (filgrastim-ayow) for Neutropenia

    What is RELEUKO and what is it used for? RELEUKO is a man-made form of G-CSF or granulocyte colony-stimulating factor. G-CSF stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight against infection. It is used to treat: Patients with Cancer Receiving Myelosuppressive Chemotherapy Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy Patients with Cancer Undergoing Bone Marrow Transplantation Patients with Severe Chronic Neutropenia Who should not take RELEUKO? RELEUKO is contraindicated in patients who have had a serious allergic reaction to human G-CSFs such as filgrastim products or pegfilgrastim products. What should I tell my doctor before using RELEUKO? Before you…