As global harmonization efforts on regulatory approaches to generic medicines continue to move forwards, the international off-patent industry has also seen recent pushes for international regulators to adopt a more streamlined approach to registering biosimilars, potentially allowing for a reduced clinical trial and data burden as stakeholders become more comfortable with using analytical tools to evaluate biosimilarity.
However, while such developments are welcome, further and faster progress could be being made, according to Suzette Kox, secretary general of the