Biosimilars, or follow-on biologics, are the names given to officially approved versions of innovator biopharmaceutical products, licensed after patent expiration of the original, innovator, biologic. Before March 22, 2010, there was no pathway for a biosimilar to be licensed in the United States; however, such legislation was provided in the Patient Protection and Affordability Act, otherwise known as the Healthcare Bill, signed into law by the President on March 22, 2010.
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