Use of nonclinical toxicity studies to support biosimilar antibody development

Regul Toxicol Pharmacol. 2021 Jun:122:104912. doi: 10.1016/j.yrtph.2021.104912. Epub 2021 Mar 1.

Authors

Lauren Mihalcik¹, Vincent Chow¹, Monica Ramchandani¹, Beth Hinkle¹, Helen J McBride¹, Herve Lebrec²

Affiliations

¹ Amgen Inc., One Amgen Drive, Thousand Oaks, CA, USA.
² Amgen Inc., One Amgen Drive, Thousand Oaks, CA, USA. Electronic address: hlebrec@amgen.com.

PMID: 33662478
DOI: 10.1016/j.yrtph.2021.104912

No abstract available

Keywords: Animal studies; Biosimilars; Drug development; In vivo studies; Pharmacokinetics/pharmacodynamics; Regulatory approval; Toxicokinetics.

MeSH terms

Antibodies / chemistry*
Biosimilar Pharmaceuticals / chemistry*
Drug Approval / methods
Humans
United States
United States Food and Drug Administration

Substances

Antibodies
Biosimilar Pharmaceuticals