Alvotech recently submitted a Citizen Petition to the FDA requesting that the agency refuse to license any ustekinumab biosimilar as interchangeable with STELARA if it is manufactured using a Chinese hamster ovary (“CHO”) cell line—and in particular Samsung Bioepis’s PYZCHIVA (ustekinumab-ttwe). Alvotech stated that “unless and until the Agency has evaluated and concluded that the differences in sialylation between the proposed interchangeable biosimilar and the reference product, STELARA (ustekinumab), do not have the potential to adversely affect half-life and clinical effectiveness—particularly with respect to therapeutic response durability.”
Alvotech states that “STELARA is produced by using a mouse hybridoma (“Sp2/0”) host cell line, which allows for more efficient sialylation of the molecule as compared to, for example, production using . . . CHO cells using recombinant DNA technology.” Further, Alvotech’s SELARSDI (ustekinumab-aekn) and Amgen’s WEZLANA (ustekinumab-auub) are also manufactured using a Sp2/o host cell line or a glyco-engineered CHO cell-line system. According to Alvotech, Samsung Bioepis’s PYZCHIVA (ustekinumab-ttwe) is “produced using CHO cells and without glycan-engineering.”
Alvotech urges the FDA not to license additional biosimilar versions of STELARA produced using CHO cells and without glycan engineering until the significance of sialylation to ustekinumab can be fully established.
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