ReviewJournal of food and drug analysis2019
The biosimilar pathway in the USA: An analysis of the innovator company and biosimilar company perspectives and beyond.
Review in Journal of food and drug analysis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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
4 citing papers in PubMed, 7 citations in OpenAlex.
- Physician Understanding and Willingness to Prescribe Biosimilars: Findings from a US National Survey.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
- Technological Advancements in Monoclonal Antibodies.TheScientificWorldJournal · 2021Review
- Public Health Impact of Using Biosimilars, Is Automated Follow up Relevant?International journal of environmental research and public health · 2020Review
- Microvascular density assessed by CD31 predicts clinical benefit upon bevacizumab treatment in metastatic colorectal cancer: results of the PassionATE study, a translational prospective Phase II study of capecitabine and irinotecan plus bevacizumab followed by capecitabine and oxaliplatin plus bevacizumab or the reverse sequence in patients in mCRC.Therapeutic advances in medical oncology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In order to improve access to costly biological treatments, a biosimilar pathway in the United States of America (USA) was enacted under the Biologics Price Competition and Innovation Act (BPCI Act) of 2009. The aim of the present study was to investigate how the health policy, the establishment of the biosimilar pathway, influenced related companies by studying their respective perspectives and strategies revealed in literatures and publicly available resources. Perspectives of companies reveal the points of concern for the biosimilar pathway, such as data requirements, patents, interchangeability, naming, and exclusivity. Innovator companies may utilize expedited programs for serious conditions, enhance patent protection, launch programs for life-cycle extension, and develop biosimilars as well. The biosimilar companies overcoming technical barriers might need to gather convincing evidence to facilitate market penetration as well as to distinguish their products from those of other biosimilar competitors. More challenges are expected for innovator companies if international harmonization takes place, which might be worth further investigation.
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.