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Biosimilars must demonstrate comparable quality, safety, and efficacy to the reference product through a comprehensive comparability exercise, not just bioequivalence as with conventional generic medications

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While compounded medications are not FDA-approved, they use FDA-approved active pharmaceutical ingredients manufactured to strict pharmaceutical standards for safety and potency

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Hypoxia-induced iron accumulation in oligodendrocytes mediates apoptosis by eliciting endoplasmic reticulum stress