Comment on “New Alternatives for Autoimmune Disease Treatments: Physicochemical and Clinical Comparability of Biosimilar Etanercept”

Response to: Comment on “New Alternatives for Autoimmune Disease Treatments: Physicochemical and Clinical Comparability of Biosimilar Etanercept”

“…As it can be seen, Figure 1 of this letter reveals correspondence between Enbrel profiles, as obtained by Miranda-Hernández et al [ 2 ] and Hassett et al [ 1 ]. Moreover, a similar profile was published by a third party assessment on Enbrel glycan heterogeneity [ 3 ] (Figure S-1 of Houel et al's “N- and O-Glycosylation Analysis of Etanercept Using Liquid Chromatography and Quadrupole Time-of-Flight Mass Spectrometry Equipped with Electron Transfer Dissociation Functionality”).…”

“…This communication responds to the Letter to the Editor [ 1 ], where noticeably Messrs. Brian Hassett, Steven Vicik, and Brian Fitzpatrick from Pfizer Biotech contended that a particular glycan profile, presented in comparison to different profiles, does not correspond to the historical profile of the reference medicinal product of etanercept (Enbrel®), as it is exposed.…”

“…In particular, an Enbrel chromatogram revealed a higher relative abundance of late eluting species. Therefore, it is suggested by Hassett et al [ 1 ] that this profile belongs instead to the etanercept biosimilar: Infinitam®, manufactured by Probiomed S.A. de C.V. Additionally, it is reasoned that the chromatogram pertaining to Infinitam is indistinguishable from the reference medicinal product, as its identity is presumed as an Enbrel profile [ 1 ].…”

“…Actually, the mistrusted glycan profile (Enbrel chromatogram in Figure 3 panel b of Miranda-Hernández et al [ 2 ]) largely corresponds to the Enbrel reference standard profile included in the Letter to the Editor [ 1 ]. We present a reproduction of both profiles as Figure 1 of this letter.…”

Variability of intended copies for etanercept (Enbrel®): Data on multiple batches of seven products

“…Moreover, the profile was distinct from those of historical batches (>2,000) and with the specification reported here, raising questions as to the validity of the physicochemical similarity exercise between the products. 35 Comparable safety and efficacy of Altebrel TM and innovator etanercept, based on a non-inferiority, randomized, doubleblind, parallel clinical trial in patients with active RA (n D 128), has been described 36 ; however, full details of this study have not been published in the peer-reviewed literature.…”