Evidence map›Paper›PMID 35743204›Full record

ArticleInternational journal of molecular sciences2022

Comparative Assessment of the Structural Features of Originator Recombinant Human Follitropin Alfa Versus Recombinant Human Follitropin Alfa Biosimilar Preparations Approved in Non-European Regions.

Lucio Manzi, Nunzio Sepe, Walter Migliaccio, Ludovica Lanzoni, Luisa Iozzino, Fabrizia D'Angelo, Lucia Colarusso, Susana Montenegro, Angelo Palmese, Thomas D'Hooghe and 3 more

Open access · goldAbstract read
In one paragraph

Article in International journal of molecular sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 11% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. 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

13 authors at 5 institutions in 6 countries.

Lucio ManziCharacterization & Innovative Analytics Unit-Analytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Merck Serono S.p.A., 00176 Rome, Italy, an affiliate of Merck KGaA.
Nunzio SepeCharacterization & Innovative Analytics Unit-Analytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Merck Serono S.p.A., 00176 Rome, Italy, an affiliate of Merck KGaA.
Walter MigliaccioCharacterization & Innovative Analytics Unit-Analytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Merck Serono S.p.A., 00176 Rome, Italy, an affiliate of Merck KGaA.
Ludovica LanzoniCharacterization & Innovative Analytics Unit-Analytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Merck Serono S.p.A., 00176 Rome, Italy, an affiliate of Merck KGaA.
Luisa IozzinoCharacterization & Innovative Analytics Unit-Analytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Merck Serono S.p.A., 00176 Rome, Italy, an affiliate of Merck KGaA.
Fabrizia D'AngeloCharacterization & Innovative Analytics Unit-Analytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Merck Serono S.p.A., 00176 Rome, Italy, an affiliate of Merck KGaA.
Lucia ColarussoCharacterization & Innovative Analytics Unit-Analytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Merck Serono S.p.A., 00176 Rome, Italy, an affiliate of Merck KGaA.
Susana MontenegroMerck Healthcare KGaA, 64293 Darmstadt, Germany.
Angelo PalmeseCharacterization & Innovative Analytics Unit-Analytical Development Biotech-Global Analytical Development-Global Development & Launch-Global Healthcare Operation, Merck Serono S.p.A., 00176 Rome, Italy, an affiliate of Merck KGaA.
Thomas D'HoogheMerck Healthcare KGaA, 64293 Darmstadt, Germany.
Alfredo Ulloa-AguirreResearch Support Network (RAI), Universidad Nacional Autónoma de México-Instituto Nacional de Ciencias Médicas y Nutrición SZ, Tlalpan, Mexico City 14000, Mexico.ORCID 0000-0002-9532-3886
Yulia KolodaDepartment of Obstetrics and Gynecology, Russian Medical Academy of Continuous Professional Education, Centre of Reproduction "Life Line", 121471 Moscow, Russia.
Monica LispiMerck Healthcare KGaA, 64293 Darmstadt, Germany.ORCID 0000-0002-9920-3208
Merck Serono (Italy) · ITMerck (Germany) · DEInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXRussian Medical Academy of Continuous Professional Education · RUUniversity of Modena and Reggio Emilia · IT

Funding

Merck (Germany) N/A
6 · The paper itself

Abstract

Although the full primary structures of the alfa and beta subunits of reference r-hFSH-alfa and its biosimilars are identical, cell context-dependent differences in the expressing cell lines and manufacturing process can lead to variations in glycosylation profiles. In the present study, we compared the structural features of reference r-hFSH-alfa with those of five biosimilar preparations approved in different global regions outside Europe (Primapur

Indexed as

Biosimilar PharmaceuticalsFollicle Stimulating Hormone, HumanGlycosylationHumansRecombinant ProteinsBiosimilar PharmaceuticalsFollicle Stimulating Hormone, Humanfollitropin alfaRecombinant ProteinsbiosimilarsglycosylationmacroheterogeneitymicroheterogeneityNeu5GcN-glycolylneuraminic acidO-acetylationpost-translational modificationsr-hFSH-alfasialylation

Identifiers

PMID35743204
PMCPMC9223809
OpenAlexW4283018036

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.