Abstract:In oncology practices across the United States, biosimilars—highly similar versions of licensed, innovator (reference) biological medicines—are currently emerging as more affordable therapeutic options. Only after a rigorous product development program, during which a proposed biosimilar is analyzed and compared with its reference biologic to demonstrate comparable clinical efficacy, safety, and tolerability, is biosimilarity supported and licensure granted by the US Food and Drug Administration. Coincidentall… Show more
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