Optimizing use and addressing challenges to uptake of biosimilars.

With the passing and implementation of the Biologics Price Competition and Innovation Act in 2010, biosimilars became a new classification of FDA-approved drugs. The biosimilar classification, created with a streamlined drug approval process, was intended to spur competition and reduce the cost of biological product therapies. Since the first FDA-approved biosimilar in 2015, the impact of biosimilars on the US biological product market remains to be seen. As more biosimilar products are approved and marketed, cost-savings are expected with predictions ranging from $54 billion to $250 billion by the mid-2020s. However, a multitude of factors may diminish the cost-saving potential of biosimilars. For biosimilars to gain market share, patients, physicians, and other healthcare professionals will need to accept biosimilars as safe and effective alternatives to reference-biologic products. A key factor in gaining this acceptance is educating the public, physicians, and healthcare professionals on the rigorous approval standards required of biosimilars by the FDA. Other factors that will affect market share of biosimilars include litigation actions by biopharmaceutical manufacturers; positions stated by physician organizations; and the influences of insurers and managed care. The clinical and basic science required for biosimilar approvals will be major underlying elements driving biosimilar acceptance and increased market presence.