Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance

Author(s): Adjunct Professor Sarfaraz K Niazi, PhD, SI, FRSB, FPAMS, FACB

Abstract: Biosimilar drugs have suffered slow entrance and acceptance rates in the US market, due not only to common misperceptions among the public but also US Food and Drug Administration (FDA) licensing laws. This review offers nine major recommendations for the FDA to simplify how biosimilars are licensed and thus make biosimilars more accessible to […]

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