ReviewCurrent rheumatology reports2016
The Regulation of Biosimilars in Latin America.
Review in Current rheumatology reports, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and Safety in the Continued Treatment With a Biosimilar Drug in Patients Receiving Infliximab: A Systematic Review in the Context of Decision-Making From a Latin-American Country.Frontiers in pharmacology · 2019Pooled it
- Advanced Breast Cancer Guidelines in Latin America: Assessment, Adaptation, and Implementation of Fifth Advanced Breast Cancer Consensus Guidelines.JCO global oncology · 2024Article
- Improving access to SLE therapies in low and middle-income countries.Rheumatology (Oxford, England) · 2023Review
- Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities.Frontiers in medicine · 2021Article
- Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America.Neurology and therapy · 2019Article
- Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey.Pharmacoepidemiology and drug safety · 2019Review
- Comparison of Physician Therapeutic Inertia for Management of Patients With Multiple Sclerosis in Canada, Argentina, Chile, and Spain.JAMA network open · 2019Article
- Mexican rheumatology: where do we stand?Rheumatology international · 2019Article
- Practical Guidance on Biosimilars, With a Focus on Latin America: What Do Rheumatologists Need to Know?Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases · 2019Review
- The Role of Prescribing Generic (Non-proprietary) Drugs in the Prevalence of Therapeutic Inertia in Multiple Sclerosis Care.Frontiers in neurology · 2018Article
- A bibliometric analysis of the global research on biosimilars.Journal of pharmaceutical policy and practice · 2018Article
- The biosimilars journey: current status and ongoing challenges.Drugs in context · 2018Review
- Regulatory Pathway for Licensing Biotherapeutics in Mexico.Frontiers in medicine · 2018Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This article summarizes the regulatory scenario on biological medications in Latin America focusing on comparability studies, extrapolation of indications, interchangeability and pharmacovigilance issues. In the case of comparability studies, what is being discussed is the possibility of decreasing the clinical trials requirement, but that the molecule should be well characterized in the studies of pharmacokinetics and pharmacodynamics. With the worldwide-level approval of the first monoclonal antibody biosimilar, infliximab, extrapolation of indications are being discussed, since the behavior of the Latin America regulatory agencies has been different with regard to such issue. Another issue discussed by the regulatory agencies is the interchangeability between biological medications and their biosimilars, mainly due to the fact that there is a clear confusion on interchangeability and substitution concepts. Finally, the pharmacovigilance debate, according to what takes place globally, is related to the need for identifying and differentiating the reference biological medication and its biosimilars for traceability purposes.
Indexed as
Identifiers
26951254What 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.