Comparability Protocols for Drugs and Biologics: Chemistry, Manufacturing, and Controls Information

PDA applauds this new draft, feels this guidance is an improvement on what was previously available, and appreciates the options provided. It clearly portrays FDA's intent to work, and partner, with applicants to achieve positive outcomes for patients. It is very helpful to have details on what information to submit. The acknowledgement and opportunity to utilize risk assessments to provide sound scientific justification to discuss post-approval changes with the agency introduces needed flexibility to the review process and is considered very helpful. PDA encourages FDA to work towards alignment of this guidance and the ICH Q12 document In addition, PDA recommends that combination products should be included in this scope. Please also clarify if there are any special considerations for Comparability Protocols (CPs) for biosimilar products.