Discover how our stepwise and tailor-made comparability analysis service further develops your biosimilar and subsequent product approval.
With you on your biologics journey...
Why do biosimilar comparability studies?
Comparability studies are a cornerstone of the biosimilar development process.
Head-to-head comparison of the biosimilar to the originator is a stepwise tailor-made process, with the overall aim of ruling out any clinical performance differences between the biosimilar product and the innovator.
3P’s biosimilar comparability studies
A comparability study is performed to assess and quantify the variation between the batches of product and innovator. As the data derived from the analysis of critical quality attributes (CQAs) is compared to reference materials, it essential to assess a range of originator material. Specifically, analysis of multiple batches and manufacturing sites is carried out wherever possible. Typically, comparability studies include material derived from engineering and cGMP batches manufactured by us and originator batches. We also recommend including a shelf-life comparison.
What we will deliver
We deliver comprehensive comparability analysis, including all required comparability documentation, to further develop your biosimilar and subsequent approval of the product.