Amanda Forys, MSPH: Now moving with this biosimilars market, we as of recently have 9 approved biosimilars. Three of them, we mentioned 2 already, in oncology there’s Zarxio, which was our first biosimilar, that [granulocyte-colony stimulating factor, G-CSF] product for supportive oncology care. That’s been on the market now since 2016.
We do have anti-cancer medications in the pipeline; really, not only is the [Biologics Price Competition and Innovation Act, BPCIA] pathway new for these manufacturers, but they now have to work through it to get approval. You’ve also got biologics that are going to be losing their exclusivity in the next few years, some of the big ones.
We definitely see a market moving in oncology. Can you talk a little bit about where you see biosimilars playing out in oncology, specific cancers, or any other disease states that you think we should really be on the lookout for these products making a difference for patients?
Christy M. Gamble, JD, DrPH, MPH: So, in the oncology space, we’re excited. There’s a lot going on there. We see the need to bring on some more biosimilars into the market, and lower that cost, as I’m going to continue to say.
We really want biosimilars, and even biologics for other disease conditions, to come onto the market and really look at oncology and see that as a model. We’re seeing psoriasis—we’ve actually seen some great movement there—but we need more innovative therapies there [and] biosimilars there.
We’re looking at lupus, the biologic for lupus is completely disturbing because you have to take other treatments in conjunction with the biologic, and it’s proven to be very ineffective. Non-Hodgkin lymphoma, rheumatoid arthritis, we would love to see biosimilars in [those] market[s].
Another thing that we would love to see, when you see these newer biologics come onto the market, the first and second generation, we would like to see the prices being lowered at that point. Seeing biosimilars come onto the market, I know there’s such a conversation around exclusivity and patents, but when you have newer biologics come on the market, that’s the conversation for lowering prices for the older therapies. So that’s what we would love to see too.
Amanda Forys, MSPH: And do you think this cost-savings, I know we’re seeing it in oncology, the CAR T-cell therapy is really coming to life, and [it’s] expensive. I mean, you’re taking a patient’s own DNA and making medication tailored to the patient. Do you think that price point and that biosimilar availability could start lowering prices system-wide to make room for therapies that costs a developer a huge amount of money to develop—we know that there is a cost to them to bring them to market and innovation does have a price tag to it—do you see this allowing that to happen more and us maybe potentially projecting to a new level of healthcare?
Christy M. Gamble, JD, DrPH, MPH: Absolutely, and I hope that we continue to move forward, bring more biosimilars to the market, and just see how this innovative therapy is going to change the healthcare system as we know it.
We definitely don’t want to bankrupt manufacturers because we know the costs that come into developing these drugs, but [we] want to make sure that patients can actually access the drug that they’re developing, and we get more manufacturers into that market where there’s some good competition there.
We’re all for any type of innovative and creative way to getting low-cost drugs and effective drugs to patients.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Stable Patient Satisfaction Found After Switching From the Humira or Biosimilar CT-P17
December 14th 2024A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.
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.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.