Biologic agents have revolutionized the treatment of many diseases, and biosimilars offer similar efficacy with potentially lower costs. However, the development of biosimilars is more complicated than the development of generic versions of small molecule drugs, thus requiring distinct approval pathways. This Special Report discusses the global regulatory landscape for biosimilars as well as the FDA's recent draft guidance for developing biosimilars.

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Understanding Key Differences Between Biosimilars and Small Molecule Generics

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