The ‘totality-of-the-evidence’ approach in the development of PF-06438179/GP1111, an infliximab biosimilar, and in support of its use in all indications of the reference product
| Autor: | Carol F. Kirchhoff, Joseph E. McClellan, Michael W. Bolt, Vatche Kalfayan, Muhammad I. Rehman, Rameshraja Palaparthy, Hugh D. Conlon |
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| Rok vydání: | 2019 |
| Předmět: |
Oncology
medicine.medical_specialty extrapolation PF-06438179/GP1111 Review Disease 03 medical and health sciences 0302 clinical medicine Internal medicine totality of the evidence medicine Clinical efficacy lcsh:RC799-869 Tumor necrosis factor binding 030203 arthritis & rheumatology business.industry Gastroenterology In vitro toxicology Biosimilar medicine.disease Infliximab Reference product 030220 oncology & carcinogenesis Rheumatoid arthritis lcsh:Diseases of the digestive system. Gastroenterology biosimilar infliximab business medicine.drug |
| Zdroj: | Therapeutic Advances in Gastroenterology, Vol 12 (2019) Therapeutic Advances in Gastroenterology |
| ISSN: | 1756-2848 |
| DOI: | 10.1177/1756284819852535 |
| Popis: | The ‘totality-of-the-evidence’ biosimilarity concept requires that sufficient structural, functional, nonclinical, and clinical data are acquired in a stepwise manner, to demonstrate that no clinically meaningful differences in quality, safety, or efficacy are observed compared with the reference product. We describe the totality of the evidence for PF-06438179/GP1111 (PF-SZ-IFX; IXIFI™ [infliximab-qbtx]/Zessly®) that supported its approval as an infliximab (IFX) biosimilar for all eligible indications of reference IFX (ref-IFX; Remicade®) in Europe and in the US. Analytical similarity involving in vitro assays capable of distinguishing structural or functional differences between PF-SZ-IFX and ref-IFX formed a foundation for the biosimilarity exercise. Differences identified in N-glycosylation and charge heterogeneity were found not to impact the results in in vitro biological assays reflective of the pharmacology underlying the mechanisms of action (tumor necrosis factor binding, reverse signaling, antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity) of IFX across disease indications. Similarity was assessed in a comparative clinical pharmacokinetic study and in a clinical efficacy and safety study in patients with rheumatoid arthritis, where therapeutic equivalence between PF-SZ-IFX and ref-IFX provided confirmatory evidence of biosimilarity, and, when coupled with the analytical similarity already established, supported extrapolation to all eligible disease indications of ref-IFX. |
| Databáze: | OpenAIRE |
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