Evidence map›Paper›PMID 33557682›Full record

ReviewmAbs

Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters.

HoUng Kim, Rieke Alten, Fraser Cummings, Silvio Danese, Geert D'Haens, Paul Emery, Subrata Ghosh, Cyrielle Gilletta de Saint Joseph, JongHyuk Lee, James O Lindsay and 7 more

Open access · goldAbstract readReview
In one paragraph

Review in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.9field-weighted citation impact, top 14% 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

17 citing papers in PubMed, 34 citations in OpenAlex.

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  11. How to select a best-value biological medicine? A practical model to support hospital pharmacists.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2022
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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

17 authors at 16 institutions in 7 countries.

HoUng KimCelltrion Healthcare , Incheon, Republic of Korea.ORCID 0000-0001-5936-582X
Rieke AltenRheumatology Research Center, Schlosspark-Klinik Charité, University Medicine Berlin , Berlin, Germany.ORCID 0000-0002-3395-4412
Fraser CummingsDepartment of Gastroenterology, University Hospital Southampton NHS Foundation Trust , Southampton, UK.ORCID 0000-0002-9659-3247
Silvio DaneseHumanitas Clinical and Research Center - IRCCS and Department of Biomedical Sciences, Humanitas University , Milan, Italy.ORCID 0000-0001-7341-1351
Geert D'HaensDepartment of Inflammatory Bowel Disease, Amsterdam University Medical Centers , Amsterdam, The Netherlands.ORCID 0000-0003-2784-4046
Paul EmeryLeeds NIHR Biomedical Research Centre, The Leeds Teaching Hospital Trust, and Leeds Institute of Rheumatic & Musculoskeletal Medicine, University of Leeds , UK.ORCID 0000-0002-7429-8482
Subrata GhoshThe Institute of Translational Medicine, Immunology and Immunotherapy, NIHR BRC, University of Birmingham , Birmingham, UK.ORCID 0000-0002-1713-7797
Cyrielle Gilletta de Saint JosephDivision of Gastroenterology, Hôpital de Rangueil CHU Toulouse , Toulouse, France.ORCID 0000-0002-1779-6880
JongHyuk LeeDepartment of Pharmaceutical Engineering, College of Life and Health Science, Hoseo University , Asan, Republic of Korea.ORCID 0000-0002-9932-8879
James O LindsayDepartment of Gastroenterology, The Royal London Hospital, Barts Health NHS Trust , London, UK.ORCID 0000-0003-3353-9590
Elena NikiphorouCentre for Rheumatic Diseases, King's College, London, and Rheumatology Department, King's College Hospital , London, UK.ORCID 0000-0001-6847-3726
Ben ParkerKellgren Centre for Rheumatology, Manchester Royal Infirmary, NIHR Manchester Biomedical Research Centre , Manchester, UK.
Stefan SchreiberDepartment of Medicine I, Christian-Albrechts-University, University Hospital Schleswig-Holstein , Kiel, Germany.ORCID 0000-0003-2254-7771
Steven SimoensDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven , Leuven, Belgium.ORCID 0000-0002-9512-2005
Rene WesthovensDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Center , Leuven, Belgium.ORCID 0000-0002-3432-3073
Ji Hoon JeongDepartment of Global Innovative Drugs, Graduate School of Chung-Ang University and Department of Pharmacology, College of Medicine, Chung-Ang University , Seoul, Republic of Korea.ORCID 0000-0001-8257-403X
Laurent Peyrin-BirouletDepartment of Gastroenterology, Nancy University Hospital , Vandoeuvre-Les-Nancy, France.
KU Leuven · BEAmsterdam University Medical Centers · NLBarts Health NHS Trust · GBCelltrion (South Korea) · KRChristian-Albrechts-Universität zu Kiel · DEChung-Ang University · KRHôpital Rangueil · FRHoseo University · KRHumanitas University · ITInserm · FRKing's College London · GBManchester Royal Infirmary · GBNIHR Birmingham Biomedical Research Centre · GBSchlosspark-Klinik · DEUniversity Hospital Southampton NHS Foundation Trust · GBUniversity of Leeds · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The biosimilar concept is now well established. Clinical data accumulated pre- and post-approval have supported biosimilar uptake, in turn stimulating competition in the biologics market and increasing patient access to biologics. Following technological advances, other innovative biologics, such as "biobetters" or "value-added medicines," are now reaching the market. These innovative biologics differ from the reference product by offering additional clinical or non-clinical benefits. We discuss these innovative biologics with reference to CT-P13, initially available as an intravenous (IV) biosimilar of reference infliximab. A subcutaneous (SC) formulation, CT-P13 SC, has now been developed. Relative to CT-P13 IV, CT-P13 SC offers clinical benefits in terms of pharmacokinetics, with comparable efficacy, safety, and immunogenicity, as well as increased convenience for patients and reduced demands on healthcare system resources. As was once the case for biosimilars, nomenclature and regulatory pathways for innovative biologics require clarification to support their uptake and ultimately benefit patients.

Indexed as

Drug DevelopmentAdministration, IntravenousAnimalsAntibodies, MonoclonalBiosimilar PharmaceuticalsCost-Benefit AnalysisDiffusion of InnovationDrug CompoundingDrug CostsHumansInfliximabInjections, SubcutaneousAntibodies, MonoclonalBiosimilar PharmaceuticalsCT-P13InfliximabBiobetterbiologicbiosimilarCT-P13infliximabinnovative biologicsvalue-added medicine

Identifiers

PMID33557682
PMCPMC7889098
OpenAlexW3127387234

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.