Publications by authors named "Vamsi K Bandi"
Background This post-marketing surveillance (PMS), observational, prospective, safety study evaluated the safety, tolerability, and long-term immunogenicity of prescribed usage of Darbepoetin alfa (DA-α, manufactured by Hetero Biopharma, Hyderabad, India) in Indian patients having chronic kidney disease (CKD) with anemia. Methods All patients having chronic kidney disease with anemia and prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients.
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- - The study compared the effectiveness and safety of Hetero's adalimumab (Mabura®) and Abbvie's adalimumab (Humira®) in Indian patients with active rheumatoid arthritis who were also on methotrexate therapy, involving 168 patients over 24 weeks.
- - At week 12, both treatments showed the same success rate (96.43%) in meeting the American College of Rheumatology 20 (ACR20) criteria, indicating therapeutic equivalence, and similar results were observed at week 24 for ACR20 and ACR50/70.
- - Adverse events were reported in both groups, with Hetero's adalimumab showing a
Following publication of the original article [1], the authors reported errors in the presentation of Tables 2, 4 and 5.
View Article and Find Full Text PDFA Prospective, Randomized, Multiple-Dose, Multi-Center, Comparative Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity of a biosimilar Bevacizumab (Test product, Hetero) and Reference Medicinal Product (Bevacizumab, Roche) in Patients of Metastatic Colorectal Cancer.
J Assoc Physicians India
June 2018
Objective: :To compare efficacy and safety of a biosimilar, Bevacizumab (Hetero) vs reference medicinal product (Bevacizumab, Roche) as first line therapy in patients with metastatic colorectal cancer (mCRC) in combination with chemotherapy.
Methods: Patients of aged 18 to 65 with histologically pre-confirmed mCRC and treatment naïve with unresectable metastatic disease or distant metastases were enrolled and randomized to receive either Hetero-Bevacizumab or RMPBevacizumab along with chemotherapy (XELOX or FOLFOX-4) regimen over a period of 24 weeks (up to 8 cycles of Hetero-Bevacizumab/RMP-Bevacizumab+ XELOX regimen (each cycle of 3 weeks) or up to 12 cycles of Hetero-Bevacizumab/ RMP-Bevacizumab + FOLFOX-4 regimen (each cycle of 2 weeks). Bevacizumab was administered at 7.
Background: Darbepoetin alfa (DA-α) is a long-acting erythropoiesis-stimulating glycoprotein which has half-life three-fold longer than that of Erythropoietin alfa (EPO). The objective of this study was to compare the efficacy and safety of DA-α injection versus EPO for treating renal anemia amongst Indian patients with end-stage renal disease (ESRD) undergoing dialysis.
Methods: Patients of either gender (aged 18-65 years) with ESRD undergoing dialysis who had hemoglobin (Hb) levels < 10 g/dL after receiving EPO were switched to DA-α (0.
Objective: To compare the antitumor efficacy, safety, and pharmacodynamics (PD) characteristics of Hetero-Rituximab (test) with Reference Medicinal Product (Rituximab, Roche) in Non-Hodgkin's Lymphoma (NHL).
Patients And Methods: Total 40 Follicular Lymphoma (FL) patients were randomized to receive intravenous infusion of either test or reference product. Efficacy (best overall response [BOR] rate [primary end point]), safety, PD (CD19), and immunological assessments (secondary end points) were done at the end of cycle 3 and cycle 6.