It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings. Biosimilars go through the same rigorous evaluation of ...

The comparability demonstration does not essentially mean that there are identical critical quality attributes of the post-change and pre-change product, but rather that they are extremely similar.

Clinical trials required by European regulators to compare biosimilar products with corresponding biologic brands are surplus to requirements and may even be a barrier for the development of ...

Forbes contributors publish independent expert analyses and insights. I am the Kester and Brynes Professor at Columbia Business School and a Chazen Senior Scholar at the Jerome A. Chazen Institute for ...

To establish whether clinical-product quality remains constant when making a process change can be a challenging exercise. Limited data availability further complicates the assessment of whether the ...

Food & Drug Administration (FDA) guidance is just now addressing the challenges of manufacturing cell and gene therapy (CGT) products with a proposed draft guidance, Manufacturing Changes and ...

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study. To assess ...

Revised guidance addresses combination products, DMFs The final version also addresses the handling of comparability protocols for combination products and DMFs. For combination products, a ...

Congress must address how current federal law masks education funding disparities between low- and higher-income students by fixing the so-called comparability loophole. For appendix tables, see the ...