Evidence map›Paper›PMID 31450637›Full record

ReviewBiomolecules2019

The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy.

Eva Rahman Kabir, Shannon Sherwin Moreino, Mohammad Kawsar Sharif Siam

Abstract readReview
In one paragraph

Review in Biomolecules, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed.

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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

3 authors.

Eva Rahman KabirDepartment of Pharmacy, BRAC University, Dhaka 1212, Bangladesh. eva.kabir@bracu.ac.bd.ORCID 0000-0001-9016-0865
Shannon Sherwin MoreinoDepartment of Pharmacy, BRAC University, Dhaka 1212, Bangladesh.
Mohammad Kawsar Sharif SiamDepartment of Pharmacy, BRAC University, Dhaka 1212, Bangladesh.ORCID 0000-0001-8882-6381

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The coming wave of patent expiries of first generation commercialized biotherapeutical drugs has seen the global market open its doors to close copies of these products. These near perfect substitutes, which are termed as "biosimilars", do not need to undergo intense clinical trials for their approval. However, they are mandated to produce identical similarity from their reference biologics in terms of clinical safety and efficacy. As such, these biosimilar products promise to foster unprecedented access to a wide range of life-saving biologics. However, seeing this promise be fulfilled requires the development of biosimilars to be augmented with product trust, predictable regulatory frameworks, and sustainable policies. It is vital for healthcare and marketing professionals to understand the critical challenges surrounding biosimilar use and implement informed clinical and commercial decisions. A proper framework of pharmacovigilance, education, and scientific exchange for biologics and biosimilars would ensure a dramatic rise in healthcare access and market sustainability. This paper seeks to collate and review all relevant published intelligence of the health and business potential of biosimilars. In doing so, it provides a visualization of the essential steps that are required to be taken for global biosimilar acceptance.

Indexed as

Biological ProductsBiosimilar PharmaceuticalsClinical Trials as TopicDrug ApprovalGovernment RegulationGuidelines as TopicHumansBiological ProductsBiosimilar Pharmaceuticalsbiologicbiosimilarbiosimilar marketchallengesimmunogenicityregulatory

Identifiers

PMID31450637
PMCPMC6770099

What OpenQuestion holds

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Registered trials

None linked

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.