The US Food and Drug Administration has announced further steps to make biosimilar development faster and less costly, with new draft guidance published on 9 March 2026.
What the draft guidance says
- Developers are encouraged to leave out clinical pharmacokinetic (PK) studies when this can be justified scientifically. The FDA estimates this could cut the cost of PK work by up to half, or around $20 million per programme.
- In some scenarios, an applicant may rely on data from a comparator product approved outside the US, without running a three-way PK study.
- An earlier recommendation to run at least one clinical PK study directly against the US reference product has been removed.
- The draft replaces the September 2021 version, and the FDA has withdrawn its 2015 final guidance on demonstrating biosimilarity, saying it no longer reflects current thinking.
Why it matters
The announcement follows an earlier FDA effort to reduce unnecessary comparative efficacy studies, which can take one to three years and cost in the region of $24 million. The agency says it has now approved 82 biosimilars, and that the changes are also intended to help developers of proposed interchangeable products.
For developers, a stronger reliance on analytical and comparability data puts more weight on well-characterised reference material from multiple batches and sources.
Source: US FDA press announcement, 9 March 2026. This is a summary, not regulatory advice. Guidance is in draft and may change.
