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Biosimilar Competition

Meaning

Biosimilar competition refers to the market dynamic that emerges when a biological product, highly similar to an already approved reference biologic drug, receives regulatory approval and enters the market. These subsequent products are not chemically identical generics, as biologics are complex molecules, but they must demonstrate clinical comparability, efficacy, and safety to the originator product. This competitive pressure is a crucial mechanism for increasing patient access to life-saving and hormone-modulating therapies like insulin and growth hormone.