The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each of the first new biosimilars for a reference product, though it may hold more if there are particular issues or concerns with a specific biosimilar application.
Marjorie Shapiro, chief of the laboratory of molecular and developmental immunology at FDA, told attendees at the annual PDA/FDA conference in Washington, DC, that the first biosimilar for each reference product will have an advisory committee, but there will not be hearings for any others “unless there’s a specific issue to discuss.”
FDA has held advisory committee hearings for all three biosimilars approved in the US to date, as well as for Amgen’s Humira (adalimumab) biosimilar.
Critical Quality Attributes
An attendee at the conference also asked FDA if it intends to publish a list of Tier 1 critical quality attributes (CQAs) to aid the process of biosimilar development. Biosimilar and biologic sponsors typically group CQAs - which are physical, chemical, biological, or microbiological properties or characteristics that should be within an appropriate limit, range or distribution to ensure the
desired product quality, according to ICH Q8 - into three main risk categories (Tier 1 being the highest).
Emanuela Lacana, associate director of biosimilars and biologics policy at FDA, clarified that in the case of already approved biosimilars, that information on CQAs is out there, but FDA “won’t issue any product specific guidance at this point. I would recommend sponsors come to us to get input earlier on expectations.”
And though Lacana said there’s been a slow trickle on which CQAs are important, she also clarified that for low-level attributes with less information, companies can use literature references to make certain judgments.
“If it’s low-level, even if you’re unsure, don’t worry too much, but if it’s a difference between 10% and 20%, know your protein. Don’t leave large, gaping uncertainties,” Shapiro said.
Other recommendations on CQAs and other concerns noted by FDA included: