Evidence map›Paper›PMID 28553081›Full record

ReviewDrug design, development and therapy2017

Ten years of biosimilar recombinant human growth hormone in Europe.

Paul Saenger

Open access · goldAbstract readReview
In one paragraph

Review in Drug design, development and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 20% of its field
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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Guideline
  2. Efficacy and Safety of Biosimilar Growth Hormone in Indian Children.Indian journal of endocrinology and metabolism
    Article
  3. Review
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

1 author at 1 institution in 1 country.

Paul SaengerDivision of Pediatric Endocrinology, Department of Pediatrics, Winthrop University Hospital, Mineola, NY, USA.
Winthrop-University Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years. With the expiration of patent exclusivity for the first wave of rhGH products and other biopharmaceuticals, the opportunity emerged for the development of biosimilar medicines. A biosimilar is defined by the European Medicines Agency (EMA) as a biological medicine that is similar to another biological medicine that has already been authorized for use. The EMA led the way (well ahead of the Food and Drug Administration in the US) in developing the biosimilar concept, and the type of science-based regulatory framework required to ensure high-quality, safe, and effective biosimilar medicines; the provisions for approval of biosimilars have been in place in Europe since 2005. Under these provisions, Omnitrope

Indexed as

Drug ApprovalBiosimilar PharmaceuticalsChildDecision MakingDrug DesignEuropeHuman Growth HormoneHumansRecombinant ProteinsBiosimilar PharmaceuticalsHuman Growth HormoneRecombinant ProteinsbiosimilarOmnitrope®recombinant human growth hormone

Identifiers

PMID28553081
PMCPMC5439961
OpenAlexW2614800367

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.