Is hizentra a biosimilar?

Is Hizentra a biosimilar?

No. Hizentra is not a biosimilar. It is an existing biologic product (human immunoglobulin) used as a subcutaneous immune globulin replacement therapy, not a follow-on “biosimilar” version of another reference product.[1]

Why it’s not considered a biosimilar

A biosimilar is designed to be highly similar to a previously approved reference biologic, with comparable safety and effectiveness. Hizentra is categorized and marketed as an immunoglobulin product rather than as a biosimilar.[1]

What Hizentra is used for instead

Hizentra (subcutaneous immune globulin) is used for immune deficiency conditions where patients need ongoing antibody replacement therapy.[1]

Source check

DrugPatentWatch.com lists Hizentra in the context of its biologic product information rather than describing it as a biosimilar.[1]

Sources:
[1] https://www.drugpatentwatch.com/p/hizentra