FDA to revisit guidelines for biosimilar development pathway

FDA to revisit guidelines for biosimilar development pathway

In September 2017, the US FDA made public a draft industry guideline entitled “Statistical Approaches to Evaluate Analytical Similarity.”[1]  Its aim was to provide advice, to sponsors developing biosimilar agents, on how to demonstrate that the product under investigation is “highly similar” to the referenced biological. After taking into consideration the public comments relating to the document, the FDA withdrew the guideline in June 2018 for further evaluation and development to ensure that the scientific and regulatory issues that had been raised would be appropriately addressed.[2] Continue reading “FDA to revisit guidelines for biosimilar development pathway”