FDA Releases Quality Considerations Guideline for Biosimilars Production
- Paul A. Calvo
- Pharmaceutical Compliance Monitor
In this article, Paul Calvo discusses the FDA's release of the first set of guidance documents outlining the methods of evaluation for regulatory approval of biosimilar products. Dr. Calvo also outlines the nine factors that should be addressed when determining biosimilarity. To read the full article, visit the Pharmaceutical Compliance Monitor website.