Draft guidance from the FDA would allow companies to scale back on the studies and trials needed to prove that a biosimilar product is close enough to an approved product. Jackyenjoyphotography/Moment RF/Getty Images

The US 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.

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. B

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