Evidence map›Paper›PMID 38675198›Full record

ArticlePharmaceutics2024

First Generic Teriparatide: Structural and Biological Sameness to Its Reference Medicinal Product.

Jimena Fernández-Carneado, Mariona Vallès-Miret, Sílvia Arrastia-Casado, Ana Almazán-Moga, Maria J Macias, Pau Martin-Malpartida, Marta Vilaseca, Mireia Díaz-Lobo, Mayte Vazquez, Rosa M Sanahuja and 2 more

Abstract read
In one paragraph

Article in Pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

12 authors.

Jimena Fernández-CarneadoBCN Peptides SA, 08777 Barcelona, Spain.
Mariona Vallès-MiretBCN Peptides SA, 08777 Barcelona, Spain.
Sílvia Arrastia-CasadoBCN Peptides SA, 08777 Barcelona, Spain.
Ana Almazán-MogaBCN Peptides SA, 08777 Barcelona, Spain.
Maria J MaciasInstitució Catalana de Recerca i Estudis Avançats (ICREA), 08010 Barcelona, Spain.ORCID 0000-0002-6915-963X
Pau Martin-MalpartidaInstitute for Research in Biomedicine (IRB Barcelona), The Barcelona Institute of Science and Technology (BIST), Baldiri Reixac 10, 08028 Barcelona, Spain.ORCID 0000-0001-5867-5535
Marta VilasecaInstitute for Research in Biomedicine (IRB Barcelona), The Barcelona Institute of Science and Technology (BIST), Baldiri Reixac 10, 08028 Barcelona, Spain.ORCID 0000-0002-1666-1300
Mireia Díaz-LoboInstitute for Research in Biomedicine (IRB Barcelona), The Barcelona Institute of Science and Technology (BIST), Baldiri Reixac 10, 08028 Barcelona, Spain.ORCID 0000-0001-8325-5188
Mayte VazquezGP-Pharm SA, 08777 Barcelona, Spain.ORCID 0009-0006-0766-4848
Rosa M SanahujaGP-Pharm SA, 08777 Barcelona, Spain.
Gemma GambúsGP-Pharm SA, 08777 Barcelona, Spain.
Berta PonsatiBCN Peptides SA, 08777 Barcelona, Spain.

Funding

BCN Peptides S.A. ; GP Pharm S.A,; Welding GmbH & Co.KG NA
6 · The paper itself

Abstract

Teriparatide is an anabolic peptide drug indicated for the treatment of osteoporosis. Recombinant teriparatide was first approved in 2002 and has since been followed by patent-free alternatives under biosimilar or hybrid regulatory application. The aim of this study is to demonstrate the essential similarity between synthetic teriparatide BGW and the reference medicinal product (RMP), and thus to ensure the development of the first generic teriparatide drug. Hence, an extensive side-by-side comparative exercise, focusing on structural and biological activity, was performed using a wide range of state-of-the-art orthogonal methods. Nuclear magnetic resonance (NMR), ion mobility-mass spectrometry (IM-MS), UV, circular dichroism (CD) and Fourier transform infrared (FTIR) demonstrated the structural similarity between teriparatide BGW and the RMP. Comparative cell-based bioassays showed that the synthetic and recombinant peptides have identical behaviors. Teriparatide BGW, as a generic drug, provides an available treatment option for patients with osteoporosis and offers clinical benefits identical to those provided by the RMP.

Indexed as

comparative studygeneric drugpeptide characterizationsamenesssynthetic peptideteriparatide

Identifiers

PMID38675198
PMCPMC11054030

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.