Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, discusses patient concerns about switching to a biosimilar.
Transcript:
So I think the whole issue of switching stable patients certainly continues to be the highlight of many debates, both for physicians as well as for associations and patient groups.
And so I do think it's something that certainly at Sandoz we take very seriously. I do think though, you know, if you think about a patient who's been well controlled on an originator product, they've already been subjected to biosimilar switching. Every batch that they've had over whatever period of time has been a biosimilar.
And so I think that they're—I totally support and understand what the concern would be. Don't mess with my—especially if you're subjected to pain. Nobody wants to go back to that world when you talk to some of these patients and the patient associations. You just wouldn't want to put anybody through that.
At the same time, given the requirements under the [Biologics Price Competition and Innovation Act, BPCIA], I think also just what we actually do in order to prove the safety and efficacy, I really think it's worth a try. I really do. I think I would say to a patient, you know, be open, give it a shot, and then the value that's created in the system to free up the capacity to fund those new innovations that are coming I think is probably worth taking the chance, in the appropriate context.
I mean, I'm not a physician. So I'm not going to give medical advice, but I definitely think that given the publications and the experience, we've had years of pretty massive switches in many of the European countries, and we haven't seen any issues emerge over time. So, while, again, I understand the concern, I just think that the safety and efficacy that we've been able to prove and demonstrate with the kind of exposure that we've had is probably worth the try.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.