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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...
Autores principales: | Reinisch, Walter, Cohen, Stanley, Ramchandani, Monica, Khraishi, Majed, Liu, Jennifer, Chow, Vincent, Franklin, Janet, Colombel, Jean-Frederic |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2021
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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 |
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