Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges (Q28079835)

Akosua Adjei

2

1 reference

Paul Baldrick

3

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Antonio da Silva

4

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Karen De Smet

5

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Richard DiCicco

6

1 reference

Seung Suh Hong

7

1 reference

Michael W. Leach

9

1 reference

James McBlane

10

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Ian Ragan

11

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Praveen Reddy

12

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Donald I. H. Stewart

13

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Amanda Suitters

14

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Jennifer Sims

15

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language of work or name

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2016

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published in

Monoclonal Antibodies

5 references

27 September 2019

27 November 2019

13 December 2019

15 August 2020

8

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issue

3

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page(s)

427-35

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Creative Commons Attribution-NonCommercial 3.0 Unported

copyright license

4 references

27 September 2019

27 November 2019

13 December 2019

Concordance of preclinical and clinical pharmacology and toxicology of therapeutic monoclonal antibodies and fusion proteins: cell surface targets

15 August 2020

cites work

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

Preclinical development of monoclonal antibodies: considerations for the use of non-human primates

20 March 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

Acceptable changes in quality attributes of glycosylated biopharmaceuticals

20 March 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

Key considerations in the preclinical development of biosimilars

20 March 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

29 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

Contribution of animal studies to evaluate the similarity of biosimilars to reference products.

29 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

Comparative nonclinical assessments of the proposed biosimilar PF-05280014 and trastuzumab (Herceptin(®)).

29 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets

29 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

Cross-species binding analyses of mouse and human neonatal Fc receptor show dramatic differences in immunoglobulin G and albumin binding

29 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies

29 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

The neonatal Fc receptor (FcRn) binds independently to both sites of the IgG homodimer with identical affinity

29 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

The design of chronic toxicology studies of monoclonal antibodies: implications for the reduction in use of non-human primates.

2 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4966840

Preclinical safety testing of monoclonal antibodies: the significance of species relevance.

2 June 2018

1 reference

https://api.crossref.org/works/10.1080%2F19420862.2016.1145331

Contribution of FcRn binding to intestinal uptake of IgG in suckling rat pups and human FcRn-transgenic mice

21 January 2018

1 reference

https://api.crossref.org/works/10.1080%2F19420862.2016.1145331

Species selection considerations for preclinical toxicology studies for biotherapeutics

21 January 2018

1 reference

12 December 2020

Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera®)

1 reference

12 December 2020

The value of non-human primates in the development of monoclonal antibodies

1 reference

12 December 2020

Regulatory forum opinion piece: differences between protein-based biologic products (biotherapeutics) and chemical entities (small molecules) of relevance to the toxicologic pathologist

1 reference

12 December 2020