ReviewInternational journal of clinical pharmacy2025
Evaluating biosimilars: safety, efficacy, and regulatory considerations in clinical studies.
Review in International journal of clinical pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparative effectiveness and safety of biosimilars versus reference biologics in rheumatoid arthritis during treatment initiation: a systematic review of real-world evidence.International journal of clinical pharmacy · 2025Pooled it
- Analytical Physicochemical and Functional Studies to Compare AryoTrust, a Follow-On Biologics, with the Originator Trastuzumab (Herceptin).Pharmaceutics · 2026Article
- Migraine, monoclonal antibodies, and monitoring: a review of pharmacovigilance in the era of biologics.Frontiers in pharmacology · 2026Review
- Creating A Multi-Criteria Decision Analysis Tool to Enhance Value-Based Purchasing of Generic and Biosimilar Medications in Saudi Arabia: A Pilot Study.ClinicoEconomics and outcomes research : CEOR · 2026Article
- Current status and trends of anti-tumor biosimilars in China from 2019 to 2023: A cross-sectional analysis.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2025Article
- Formulation of Recombinant Therapeutic Proteins: Technological Innovation, Regulations, and Evolution Towards Buffer-Free Formulations.Pharmaceutics · 2025Review
- Biosimilars Targeting Pathogens: A Comprehensive Review of Their Role in Bacterial, Fungal, Parasitic, and Viral Infections.Pharmaceutics · 2025Review
- Safety outcomes in 2132 Danish patients with inflammatory arthritis treated with biosimilar infliximab (GP1111) in routine care.Therapeutic advances in musculoskeletal disease · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
Biosimilars are a rapidly growing area of clinical research, yet they encounter significant challenges, especially in emerging markets where regulatory and clinical hurdles differ markedly from those in established regions like Europe and the US. This commentary addresses these unique challenges and offers new perspectives on the global adoption of biosimilars. It emphasizes the crucial role of real world evidence in supporting biosimilar approvals, an aspect often underrepresented in current literature. The commentary also provides a comparative analysis of the regulatory frameworks in China and Europe, highlighting how these differences shape biosimilar development and market approval processes. By focusing on the issues of indication extrapolation and immunogenicity, this commentary highlights the necessity of continuous real-world data collection to ensure the safety and efficacy of biosimilars across multiple indications. Our analysis enhances the understanding of biosimilar research and supports their broader adoption as safe, effective, and accessible healthcare solutions globally.
Indexed as
Identifiers
What OpenQuestion holds
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.