Biosimilars is a biologic medication that is highly similar to an already approved reference product. It has no clinically meaningful differences in terms of safety, purity, and potency compared to the reference product. As lower-priced versions of originator biologics, biosimilars can offer patients more affordable options. However, regulatory approval hurdles, patent disputes and reimbursement barriers have impeded patient access in the United States. getty

The Food and Drug Administration Commissioner Marty Makary announced last week that his agency will expedite the biosimilar approval process by eliminating what he called “unnecessary red tape,” helping to speed lower-cost treatments to market. But in the United States, the greater impediments to patient access to biosimilars hav

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