WHO Releases Draft Guidance on Postmarket Changes to Biologics
The World Health Organization's (WHO) Expert Committee on Biological Standardization (ECBS) recently released a new draft guideline detailing the agency's proposed approach to handling changes to approved biologics and biosimilars for public comment.
Specifically, the guideline, which covers both biologics (referred to as biotherapeutic products) and biosimilars (referred to as similar biotherapeutic products (SBPs)), details the procedures and data requirements for a range changes to biological products that occur after marketing.
"Changes are essential to maintain the manufacturing process and state-of-the-art controls of biotherapeutics products (including SBPs) and often need to be implemented after the product has been approved," the guideline states.
These changes can occur for a variety of reasons, ranging from manufacturing changes or the use of different raw materials to changes in labeling for new warnings or dosages.
However, WHO cautions that "any change to a biotherapeutic product (including SBPs) may impact quality, safety, and/or efficacy."
In general, the guideline calls on companies to decide whether they need to submit a supplemental application to regulators for each change to an approved biologic based on the results of pre- and post-change analytical testing.
In addition to changes with a major or moderate impact, "all changes, regardless of the impact on quality, safety, and efficacy, should be recorded and retained by the manufacturer or [marketing authorization] holder."
The draft also noted: "In general, no change should be implemented without the approval of the NRA [national regulatory agency] unless exempted in these guidelines (i.e. minor quality changes or quality changes with no impact)."
WHO is asking stakeholders to submit comments on the guidelines by 16 December 2016.