Stakeholders want the US Food and Drug Administration (FDA) to include biosimilars and other biologics regulated by the Center for Biologics Evaluation and Research (CBER) in the agency’s guidance on benefit-risk principles when evaluating product quality assessments.
In May, FDA published the Benefit-Risk Considerations for Product Quality Assessments draft guidance which applies to new drug applications (NDA), biologics license applications (BLAs) and supplements. It outlines possible mitigation strategies for product quality issues and the circumstances under which unresolved quality issues may be addressed during a public health emergency or a widespread drug shortage. (Related: FDA offers insight into product quality assessment principles, Regulatory Focus 11 May 2020)
Specifically, FDA says it will take a risk-based approach to product quality assessments to prevent potential shortages and consider mitigation strategies where there may be quality concerns. The risk of unresolved quality issues may be outweighed by the benefit of the product or the ability to bring it market quickly according to regulators, especially if the product addresses an unmet medical need…
