Business · Companies · 1 hr ago
South Korean firms get no US or European biosimilar approvals this year
South Korean biosimilar firms won no US or European approvals this year.
The Korea Biotechnology Industry Organization reported the figures, citing data from BioPharma APAC.
Biosimilars are copy versions of biological medicines.
The US Food and Drug Administration and the European Commission approved 21 biosimilars between them this year.
The US approved nine from January to September.
The figures show a pause in approvals for South Korean firms as regulators continue to approve biosimilars overall.
South Korean biosimilar companies received no product approvals in the United States or Europe this year, according to a report cited on November 1.
The Korea Biotechnology Industry Organization said the report drew on data compiled by BioPharma APAC.
The US Food and Drug Administration and the European Commission approved 21 biosimilars in total this year.
The FDA approved nine biosimilars from January through September.
- Who
- South Korean biosimilar companies.
- What
- They received no product approvals in the United States or Europe this year.
- When
- This year, as reported on November 1, 2026.
- Where
- The United States and Europe.
- Why
- Not stated.
This story does not have two clearly opposing sides.
This story does not have a timeline yet.
- South Korean approvals
- 0 in the United States and Europe this year
- Total approvals
- 21 biosimilars approved by the FDA and European Commission this year
- US approvals
- 9 biosimilars approved from January through September
- Report source
- Korea Biotechnology Industry Organization, citing BioPharma APAC data