Biologic drugs need strict oversight

Many people in Augusta live with serious diseases every day, including cancer, diabetes, HIV/AIDS and arthritis. They depend on pharmaceuticals, particularly biologics, to live a better quality of life. As a patient battling lupus, I know that biologics are helping many people, and we need to make sure it stays that way. Biologics especially hold a lot of promise for patients with lupus since there have not been any pharmaceuticals introduced in the past 40 years designated to treat lupus.

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



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