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A Review of the Totality of Evidence for the Development and Approval of ABP 710 (AVSOLA), an Infliximab Biosimilar

ABP 710 (AVSOLA(®)) is a biosimilar to infliximab reference product (RP), a monoclonal antibody targeting tumor necrosis factor alpha (TNFα). It is approved in the USA and Canada for all the same indications as infliximab RP. Approval of ABP 710 was based on the totality of evidence (TOE) generated...

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Detalles Bibliográficos
Autores principales: Reinisch, Walter, Cohen, Stanley, Ramchandani, Monica, Khraishi, Majed, Liu, Jennifer, Chow, Vincent, Franklin, Janet, Colombel, Jean-Frederic
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8799530/
https://www.ncbi.nlm.nih.gov/pubmed/34757601
http://dx.doi.org/10.1007/s12325-021-01944-y