Biosimilar Publications


Industry Publications from BioAgilytix’s Expert Scientists

Explore the list of recent biosimilar publications to which BioAgilytix’s scientists have contributed:

Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs
Civoli F, Kasinath A, Cai XY, Wadhwa M, Exley A, Oldfield P, Alvandkouhi S, Schaffar G, Chappell J, Bowsher R, Devanarayan V, Marini J, Rebarchak S, Anderson M, Koppenburg V, Lester T. AAPS J (2020) 22: 7. doi: 10.1208/s12248-019-0386-y.
Access Here

Recommendations for the Development and Validation of Neutralizing Antibody Assays in Support of Biosimilar Assessment
Gouty D, Cai CC, Cai XY, Kasinath A, Kumar V, Alvandkouhi S, Yang J, Pederson S, Babbitt B, Peritt D, Rudy A, Koppenburg V, Dasilva A, Ullmann M, Liu S, Satterwhite C. AAPS J. 2017 Dec 28;20(1):25. doi: 10.1208/s12248-017-0181-6.
Access Here

Meeting the Rigorous Demands of Biosimilar Pharmacokinetics
Mansouri S, Zemo J, Alligood K. International Journal of Pharmacokinetics 2017 Jan; DOI 10.4155/ipk-2016-0024
Access Here

Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments
Marini J, Anderson M, Cai XY, Chappell J, Coffey T, Gouty D, Kasinath A, Koppenburg V, Oldfield P, Rebarchak S, Bowsher R. AAPS J. 2014 Nov; 16(6). doi: 10.1208/s12248-014-9669-5
Access Here

Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development.
Cai XY, Wake A, Gouty D. Bioanalysis. 2013 Mar; 5(5):517-20. doi: 10.4155/bio.13.1.
Access Here

Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development.
Cai XY, Gouty D, Baughman S, Ramakrishnan M, Cullen C. Bioanalysis. 2011 Mar; 3(5):535-40. doi: 10.4155/bio.11.24. Review.
Access Here


Speak to a Scientist

With whom will we be speaking?

I consent to receive communications (which may include, phone, email, social, and re-targeting ads) from BioAgilytix. I understand I may proactively manage my preferences or opt-out of communications with BioAgilytix at any time using the unsubscribe link provided in all of BioAgilytix’s email communications and can learn more by reading the privacy policy.

Yes I confirm that I am over the age of 16 and I consent to communications from BioAgilytix.