A Senate committee Thursday, kicked off what may become an intense debate over a bill to give the Food and Drug Administration authority to approve generic versions of bioengineered drugs.
At issue is whether generic companies can produce knock-offs of biologic drugs as safely and effectively as they do traditional or “small molecule” medicines. Small molecules are produced through chemical synthesis, and generic firms only need to show their versions have the same effect as their branded counterparts. They don’t need to submit their products for expensive clinical testing in human volunteers.
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