Ankit Patel, Niraj Bhatt, S S Prakash, Ghanashyam Biswas, Rajnish Nagarkar, Bodhisatta Roy, Priyanka Samal, Narendra Agrawal, Sushil Meshram, Ashish Kaushal, C T Satheesh, Ravikumar Wategaonkar, Kasi Viswanathan Thiagarajan, Kartikeya Jain, P Vijayaveeran, Kalyan Mukherjee, Kishore Singh, Tushar Patil, Amit Jain, Tuphan Kanti Dolai, Minish Jain, Sachin Hingmire, Tara Chand Gupta, K C Lakshmaiah, Deepan Rajamanickam, Bhushan Nemade, Vikash Goyal, Pinaki Mahato, Sanjeev Kumar Mendiratta, Maulik Doshi
PURPOSE: Very few studies have demonstrated the rituximab biosimilarity in terms of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity in patients with diffuse large B-cell lymphoma (DLBCL) in India. Therefore, we compared the efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity of our biosimilar rituximab with the reference rituximab (Ristova, Roche products [India] Pvt. Ltd) in patients with DLBCL in India. METHODS: A phase 3, randomized, assessor-blind, parallel-group, two-arm study was conducted across 28 sites in India...
April 24, 2023: Cancer Chemotherapy and Pharmacology