Evidence map›Paper›PMID 40421128›Full record

ArticleTherapeutic advances in medical oncology2025

Efficacy and safety of rituximab biosimilar (DRL_RI) versus MabThera

Narendra Maharaj, Dharma Rao Uppada, Anand Eswaraiah, Ranjith Kakkattu, Pramod Reddy, Volha A Kalenik, David Belada, Ana Oliveira Ramos, Jin Seok Kim, Yauheni V Baranau

Registry-linked trialAbstract read
In one paragraph

Article in Therapeutic advances in medical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03976102 (A Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03976102 phase3completednot on this map

A Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in Subjects With Previously Untreated (CD)20-Positive LTB Follicular Lymphoma

TypeinterventionalSponsorDr. Reddy's Laboratories LimitedRan2019 to 2023Enrolled317ConditionsFollicular LymphomaArmsDRL_RI (Proposed rituximab biosimilar), MabThera®
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Narendra MaharajBiologics Division, Dr. Reddy's Laboratories Ltd, Bachupally, Hyderabad, Telangana 500090, India.ORCID https://orcid.org/0009-0002-6713-5447
Dharma Rao UppadaDr. Reddy's Laboratories Ltd, Hyderabad, Telangana, India.
Anand EswaraiahDr. Reddy's Laboratories Ltd, Hyderabad, Telangana, India.
Ranjith KakkattuDr. Reddy's Laboratories Ltd, Hyderabad, Telangana, India.
Pramod ReddyDr. Reddy's Laboratories Ltd, Hyderabad, Telangana, India.
Volha A KalenikN. N. Alexandrov National Cancer Center, Center of Belarus, Minsk Region, Republic of Belarus.
David BeladaFakultini Nemocnice, Hradec Kralove, IV. Interni Hematologicka Klinika, Hradec Kralove, Czech Republic.
Ana Oliveira RamosHematología Clínica, Unidad Funcional de Linfomas, ICO-Hospital Duran i Reynals, Hospitalet, Barcelona, Spain.
Jin Seok KimDivision of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Severance Hospital, Seodaemun-gu, Seoul, Korea.
Yauheni V BaranauMinsk City Clinical Oncology Center, Minsk, Republic of Belarus.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and objectives: This phase III study (RI-01-006; FLINTER) was conducted to demonstrate equivalent efficacy of DRL_RI to EU-approved rituximab (MabThera Design and methods: Previously untreated, stage II-IV, CD20-positive LTB-FL patients ( Results: The BORR up to Week 28 was 80.2% versus 79.4% for DRL_RI versus MabThera group; with a difference of 0.89% (90% CI: -6.67 to 8.48; 95% CI: -8.05 to 9.93 within the prespecified margin). Both treatment groups were comparable for all secondary efficacy end points. Treatment-emergent adverse events were reported in 68.6% of patients; safety, immunogenicity, and mean serum concentrations were similar between groups. Peripheral B-cell counts declined below quantifiable limits in most patients, with a median time to B-cell depletion of 6.9 versus 7.0 days for DRL_RI versus MabThera. Conclusion: The study demonstrated efficacy equivalence of DRL_RI to MabThera; with comparable safety, immunogenicity, serum concentrations, and PD between groups. Trial registration: This trial was registered at ClinicalTrials.gov identifier: NCT03976102 and EudraCT (2018-004223-36).

Indexed as

biosimilarefficacyequivalencefollicular lymphomaimmunogenicitypharmacodynamicspharmacokineticsrituximabsafety

Identifiers

PMID40421128
PMCPMC12104602

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.