ACELLBIA®

Rituximab injection for IV Use – 100 mg/500 mg

Rituximab biosimilar, chimeric monoclonal antibody which specifically binds to the transmembrane antigen CD20

  • Indication: : ACELLBIA® has been approved by Director Controller General of India (DCGI) for the following indications:
    1. Non–Hodgkin’s Lymphoma(NHL):
      • Patients with relapsed or chemo resistant indolent B-Cell Non-Hodgkin’s Lymphoma
      • Previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy
      • For patient with relapsed/ refractory follicular lymphoma as maintenance therapy after responding to induction therapy after with chemotherapy
      • Patients with CD20 positive diffuse large B-Cell Non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy
    2. Chronic Lymphocytic Leukemia(CLL):
      • ACELLBIA® in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory Chronic Lymphocytic Leukemia

Dosage and Administration :

NHL: The recommended dose is 375 mg/m2 as an intravenous infusion,

CLL: 375 mg/m2 the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2-6 (every 28 days),

Composition :Each 10 mL/50mL single use vial contains: Rituximab 100 mg/500 mg

  • Biosimilar Quality : Similarity proven based on assured quality, safety, & efficacy evidence.
  • Manufactured in world class PIC/s approved plant in Russia
  • 174 global patients trial data with safety data of >60,000 patients treated in 8 countries.
  • The BIORIX study proves that ACELLBIA® & innovator drug have equivalent efficacy, safety & pharmacokinetics.

For more information regarding ACELLBIA®, please contact your local sales representative or email us at info@sayretherapeutics.com