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.
Transcript
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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
British Columbia’s Biosimilar Policy Shows No Impact on Hospital Visits
May 28th 2025Despite a dramatic shift toward biosimilar use following British Columbia’s policy, researchers found no rise in hospital visits or complications, underscoring the real-world reliability of etanercept biosimilars in managing inflammatory arthritis.