Currently, biologic medications approved using one manufacturing method would essentially have to start over with a new drug application to make a change in the way the medication is made. The newer medications can take advantage of manufacturing advances occurring since the first drug was launched. In addition, the truncated approval process brings savings that may be seen in lower prices.
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“I know the rheumatology community is very concerned about biosimilars and we at CDER fully expect any biosimilar approved to have the same properties as the innovators,” says Dr. Woodcock. “At the clinical level, by the time the FDA approves, the rheumatologists should have a high level of confidence that one is pretty much the same as the other.”
Dr. Kay agrees, noting, “If a biosimilar successfully gets through the specified regulatory approval process, I would be very comfortable prescribing it to my patients.”
There are 11 medications in the FDA pipeline. Dr. Woodcock could not say when the first one might come to market. She says that will depend on when sponsors can complete the studies and comparisons that have to be done.
Kurt Ullman is a freelance writer based in Indiana.