Even though they hold promise, they are complicated because they are made up of living organisms and are typically injected. The process of creating a biologic is very complex and hard to replicate. Because it is nearly impossible to replicate the manufacturing process, a follow-on biologic (for comparison's sake, a "generic" biologic) will not be the same as an original biologic. Without proper testing, they pose a threat to people who depend on them.
Current scientific methods are unable to establish that biologic products made by two different manufacturers are identical. Any legislation establishing a regulatory approval pathway for follow-on biologics should require clinical trials to demonstrate that the follow-on product is safe and effective, rather than allowing an abbreviated approval process similar to generic medications.
With hope on the horizon for those of us with lupus -- a hope that we have not realized in 40 years -- I would hate to have a generic "equivalent" compromise my safety and others' because of inferior testing requirements.
Vera Butler, Augusta