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Biosimilars and Patient Safety
Under the Affordable Care Act, Congress authorized the FDA to create a new pathway for the approval of copies of next-generation biologic drugs that are already approved and on the market. These copies, called biosimilars, are near-reproductions of a biologic drug, and if manufactured safely they can expand access to life-saving, life-enhancing medicines. However, a small difference in manufacturing process or in the cell line can alter the molecular structure between an original product and its biosimilar copies. Even slight variations could result in serious health implications for patients. So, how would you feel about replacing your drugs with biosimilars?