What is a biologic?
Biologics are a class of treatments derived from living cells that target specific parts of the immune system treating a growing list of diseases. Currently there are biologics in Canada that are approved for psoriasis, psoriatic arthritis, and metastic melanoma, and others in the approval pipeline.
What is a Subsequent Entry Biologic ( SEB)?
SEBs, also referred to as ’bio-similars’ are similar (not identical) versions of an existing biologic medication. Given that biologics are vastly more complex molecules than regular medications, manufacturers of SEBs cannot guarantee that their reproduction is identical to the originator drug. Unlike generics, where the active ingredient is the same, SEB’s are merely similar.
Health Canada has stated the following:
SEBs are not “generic” biologics. Authorization of an SEB is not a declaration of pharmaceutical or therapeutic equivalence to the reference biologic drug.
Current biologics available in Canada (refer back for updates)Enbrel (etanercept)
Stelara ( ustekinumab)
Current SEBs Approved by Health Canada (refer back for updates)