BIO Submits Comments on WHO Guideline: Nonclinical and Clinical Evaluation of Monoclonal Antibodies and Related Biological Products Intended for the Prevention or Treatment of Human Infectious Diseases
October 28, 2022
On October 28th, BIO submitted comments to the World Health Organization on its new draft guideline containing regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on an immunoglobulin framework. In the comments submitted, BIO stated strong support for WHO’s mission to ensure the equitable and widespread availability of safe, effective, and quality health products. With this objective in mind, BIO also provided several overarching recommendations. First, BIO encouraged further incorporation of the 3Rs principles (replacement, reduction, and refinement of animal use) throughout the guideline. While nonclinical in vivo studies continue to provide critical information to sponsors and regulators on the safety and efficacy of products, BIO urged WHO to reconsider when such studies are truly necessary in the context of this guideline as in vitro technologies and computational models (e.g., physiological based pharmacokinetic models) can be leveraged to inform nonclinical assessments. BIO also suggested that WHO refine the guideline broadly to ensure consistency with existing international guidelines, such as the ICH S6 Guideline. Furthermore, BIO stated that the acknowledgement and incorporation of current regional guidances where possible and applicable, especially those that have been issued since the COVID-19 pandemic, would be beneficial.
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…
On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of…
.png){kind=logo}
On October 28th, BIO submitted comments to the World Health Organization on its new draft guideline containing regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on an immunoglobulin framework. In the comments submitted, BIO stated strong support for WHO’s mission to ensure the equitable and widespread availability of safe, effective, and quality health products. With this objective in mind, BIO also provided several overarching recommendations. First, BIO encouraged further incorporation of the 3Rs principles (replacement, reduction, and refinement of animal use) throughout the guideline. While nonclinical in vivo studies continue to provide critical information to sponsors and regulators on the safety and efficacy of products, BIO urged WHO to reconsider when such studies are truly necessary in the context of this guideline as in vitro technologies and computational models (e.g., physiological based pharmacokinetic models) can be leveraged to inform nonclinical assessments. BIO also suggested that WHO refine the guideline broadly to ensure consistency with existing international guidelines, such as the ICH S6 Guideline. Furthermore, BIO stated that the acknowledgement and incorporation of current regional guidances where possible and applicable, especially those that have been issued since the COVID-19 pandemic, would be beneficial.