Gillian Woollett, MA, Dphil, vice president and head of regulatory strategy and policy at Samsung Bioepis, reviews some of the presentations, including her own, from the Festival of Biologics conference.
Gillian Woollett, MA, Dphil, vice president and head of regulatory strategy and policy at Samsung Bioepis as well as an Advisory Board member for The Center for Biosimilars®, summarizes some of the presentations, including her own, from the Festival of Biologics conference that was held in San Diego, California.
What presentations at the Festival of Biologics did you enjoy checking out and what do you hope to see more of at future conferences?
Woollett: It was an interesting meeting, of course. With FDA, it's always important to see what they're doing. Unfortunately, they have a travel ban. So, they weren't in person, but there were videos. And they had some nice updates. I mean, there's a certain preoccupation with user fees, because it's critical to the funding of the FDA. But in general, I think it was just a catch up for everyone. And FDA also had a session on biosimilar educational materials. So, those are worth checking out on their website. They've done a lot of work on that over the last year or so. So, they were flagging some of those presentations. And I think more than anything, it was just catching up with progress. And of course, everybody anticipating 2023.
To reference to the title of your presentation at the Festival of Biologics, what does global progress with biosimilars mean for the United States?
Woollett: So, what was interesting on that is there's the presumption that the US is late. But the US is only late in the sense that some of the IP [intellectual property] issues that have meant that products were approved later and launched later. But the science in the US has always been somewhat ahead, given that FDA led the world with comparability. So, it was both a discussion that the US is ready as a scientific and regulatory matter, but also that we're going to have this interesting opportunity of experience from elsewhere by the time those same biosimilars are approved in the US. So, there was a discussion around real world evidence, the fact that there has been no case of any unusual or unexpected adverse event with any of the biosimilars approved in Europe or the US. So, that was all good news. And then the issues are around, of course, the appearance of delays, but I think the FDA is ready. And some of the arguments about more efficient development and perhaps reductions in the clinical trials, the confirmatory head-to-head clinical trials, are being led by Europe too. So, if you've got the experience and you've got the clinical trials done, there's progress towards global reference. I think there's an expectation of opportunities for efficiency all around.