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.
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