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

Abstract EN

In their publication, Miranda-Hernandez et al.

2016 [1] present data on the physicochemical and biological comparability of Infinitam® with the reference etanercept innovator product, Enbrel®.

As part of a physicochemical similarity exercise (not comparability), the authors present data on glycan microheterogeneity using hydrophilic interaction ultra-performance-liquid-chromatography (HILIC-UPLC) on three batches of Enbrel and one batch of Infinitam (Figure 3 panel b of Miranda-Hernandez et al.).

We have presented a reproduction of Figure 3 panel b as Figure 1, and, for clarity, have labelled each chromatogram (a–d) (top to bottom).

Miranda-Hernandez et al.

present the top two and the bottom chromatograms as different batches of Enbrel (Figures 1(a), 1(b), and 1(d)).

The third chromatogram (Figure 1(c)) is presented as one batch of Infinitam.

We found the results in chromatogram a to be inconsistent with historical Enbrel manufacturing experience.