USA – 2021 might be breakthrough year for biosimilars

In 2019, Scott Gottlieb, former Food and Drug Administration (FDA) commissioner, argued against throwing in the towel on biosimilars, as some other experts had advised. Gottlieb was right.

The growth in biosimilar market share from late 2018 until now has been remarkable.

Biosimilars are biologics that are highly similar to a reference or originator biologic product. There are no meaningful clinical differences in safety and effectiveness between a biosimilar and its reference product…