Evidence map›Paper›PMID 32072477›Full record

ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2020

Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin

Liqi Xie, Erhui Zhang, Yanpeng Xu, Wenyuan Gao, Linlin Wang, Michael Hongwei Xie, Peilan Qin, Lihong Lu, Sipeng Li, Pengcheng Shen and 2 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
2.3field-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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

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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

12 authors at 1 institution in 1 country.

Liqi XieShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Erhui ZhangShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Yanpeng XuShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Wenyuan GaoShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Linlin WangShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Michael Hongwei XieShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China. michael_xie@henlius.com.ORCID http://orcid.org/0000-0003-0680-8732
Peilan QinShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Lihong LuShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Sipeng LiShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Pengcheng ShenShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Weidong JiangShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Scott LiuShanghai Engineering Research Center of Anti-tumor Biologic Drugs, Shanghai Henlius Biotech., Inc., Shanghai, China.
Viva Biotech (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties as well as nonclinical and clinical outcomes.

objectivesThe aim was to assess the analytical similarity between the trastuzumab biosimilar HLX02 and Europe-sourced Herceptin

methodsA panel of highly sensitive and orthogonal methods, including a novel Fc gamma receptor IIIa (FcγRIIIa) affinity chromatography technique that enables quantitative comparison of glycan effects on effector function, was developed for the assessment. To ensure the full product variability was captured, ten batches of HLX02 were compared with 39 RP batches with expiry dates from August 2017 to March 2021.

resultsThe extensive three-way similarity assessment demonstrated that HLX02 is highly similar to the RPs. Furthermore, the %afucose, %galactose, and FcγRIIIa affinity of the RPs were observed to first decrease and then return to the original level in relation to their expiry dates, and the RP batches can be subgrouped by their FcγRIIIa affinity chromatograms. HLX02 is demonstrated to be more similar to the RPs of the high FcγRIIIa affinity group.

conclusionBesides having an overall high analytical similarity to both EU-Herceptin

Indexed as

Antibodies, Monoclonal, HumanizedBiosimilar PharmaceuticalsChromatography, AffinityHumansReceptors, IgGTrastuzumabAntibodies, Monoclonal, HumanizedBiosimilar PharmaceuticalsFCGR3A protein, humanReceptors, IgGTrastuzumabtrastuzumab biosimilar HLX02

Identifiers

PMID32072477
PMCPMC7211197
OpenAlexW3006846120

What OpenQuestion holds

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LicenceCC BY-NC
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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.