The U.S. Congress is speeding up legislation to ease regulations on biosimilars (biosimilar). The aim is to reduce clinical trial burdens and expand the market. Korean drugmakers are expected to find it easier to enter the U.S.
On the 23rd, according to the Korea Biotechnology Industry Organization Bioeconomy Research Center, a U.S. House standing committee recently passed two bills on expedited access for biosimilars and regulatory easing unanimously. Further legislative steps, including a full Senate vote, are required.
The expedited access bill would abolish the legal requirement to conduct pharmacokinetic studies and comparative clinical efficacy assessments when applying for biosimilar approval. The clinical timeline is expected to shorten and expense to be reduced.
The regulatory easing bill would remove the legal distinction between biosimilars and interchangeable biosimilars. Interchangeable biosimilars can be substituted for the original drug. In the United States, pharmacies need separate studies assessing permissibility to switch a prescribed drug to a biosimilar. With the legal distinction removed, substitutions are expected to become easier.
This U.S. policy is also seen as an opportunity for Korean drugmakers. The Food and Drug Administration (FDA) has approved a total of 87 biosimilars from 2015 through the first half of this year. Among them, U.S. products (31) are the most, with Korea (19) in second place.