Amanda Forys, MSPH: Let’s talk a little bit more about the FDA. A recent paper argued that bridging studies are redundant and should not be required in the clinical development of biosimilars. What potential challenges could be associated with using a single global reference product?
Molly Burich, MS: As Dr Worthing mentioned, it’s a great question. Reference products, in a lot of ways, are biosimilar to themselves. Your product that was created in 1998 looks very different than what’s being manufactured in 2017. I think that the FDA, including bridging studies between the United States, the European Union product, and the biosimilar is really just trying to ensure that any differences (that would be natural because of the process of these) are accounted for, clinically, and are reflected in the clinical data of the product. It’s certainly possible that the agency’s thinking evolves as the biosimilar pathway evolves.
For now, I think the bridging study that’s required makes a lot of sense to, again, build that confidence in physicians who will write prescriptions for biosimilars, payers who will potentially require them, and patients who ultimately take them and want to make sure they’re getting a high-quality product that’s not going to create any issues with their disease.
Ha Kung Wong, JD: Yes, I have to agree with that. I’ll just say that biological products, with different manufacturing sites and, of course, post-approval changes in manufacturing (and this is something that Angus and Molly mentioned as well), there is some product drift. There can be some issues there. You don’t want to have differences that emerge in the critical quality attributes of the product. So, I agree. It definitely makes sense the way it is.
Biosimilars Regulatory Roundup for September 2023—Podcast Edition
October 1st 2023On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.
IQVIA Highlights Opportunity to Cash In on Biosimilars for Biologics Losing Market Exclusivity
November 29th 2023A report from IQVIA noted that Europe could miss out on €15 billion in cost savings by not having biosimilars for medications about to lose market exclusivity, shedding light on the implications for overall health care savings and ultimately, patient access.
Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?
September 17th 2023On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).