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The Safety of Biosimilars and FDA Regulation

LegitScript’s President, John Horton, recently submitted a guest blog regarding biologics (drugs made from living organisms) at the popular medical blog kevinmd.com.

At issue:

…the safety standards to which “biosimilars” — copycat version of the original biologics — will be held by the FDA.

The guest blog discusses the debate occurring in Washington, D.C. over the safety standards that biologic drugs will be held to. The article concludes:

Even if a biosimilar can never be physically identical to the original biologic, the FDAshould hold it to the same high safety standards that protect patients from harm…(this) will determine if, 100 years from now, biosimilars are seen as a historic medical advance or as a dangerous aberration in the forward march of medicine and health.