FDA to streamline approvals for generic biological drugs in latest move targeting health costs

CNN —

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate approvals for cheaper alternatives for medications used to treat a wide range of illnesses, leading to increased market competition and lower drug costs for Americans.

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Biologic drugs are developed using living sources such as bacteria, yeast, and animal cells, which inherently creates more variation and makes manufacturing more complex than for chemically derived drugs. Biologics have a special pathway to FDA approval, and biosimilars — alternatives to the brand name products — are also treated diffe