Biosimilars and what’s new in cell and gene therapies

cell therapy

This week on the podcast, we have a conversation with Fran Gregory, vice president of Emerging Therapies at Cardinal Health. 

The discussion covers the company’s role in healthcare, biosimilars, the latest in cell and gene therapies, and Advanced Therapies Week.

Table of contents

    About Cardinal Health

    Cardinal Health is a distributor of pharmaceuticals and a global manufacturer and distributor of medical and laboratory products. It also provides performance and data solutions for healthcare facilities. The company operates in more than 30 countries and has approximately 48,000 employees globally.

    Cardinal Health covers a range of functions, and Gregory oversees the specialty solutions segment, which is call Emerging Therapies. 

    This encompasses the biosimilar segment, and the cell and gene therapy center of excellence, known as Advanced Therapy Solutions. 

    Gregory said the company does not manufacture pharmaceuticals in the cell and gene therapy space. Cardinal Health provides end-to-end resources for manufacturers. The company assists with clinical development programs, and getting products through to commercialization, including distribution. This also encompasses reimbursement support programs and logistics.

    “One of the things that we’re developing right now with a number of organizations is really creating that value story around cell and gene therapy products,” Gregory said. 

    “How do we show not only the real-world evidence, but the total cost of care and the pharmacoeconomic value of these products?”

    How important is innovation to Cardinal Health?

    Gregory said Cardinal Health is committed to innovation. 

    “I think you have to be innovative. I think some of the areas where we’re showing that we are continuing to innovate is in the cell and gene therapy space. We are absolutely working to lead the market here,” Gregory said.

    “And really, we call ourselves the innovation partner for our pharmaceutical manufacturers. So we really want to continue to find new solutions to new challenges that are presented to the health care system every day, not only in cell and gene, but very broadly across health care.”

    Tackling the financial burden of cell and gene therapies

    Cell and gene therapy has become known for the sometimes high cost of treatments. 

    “We can’t keep spending at the rate that we are,” Gregory admitted.

    “And I think we all hear very frequently that the U.S. health care system, at the rate that we’re going, is somewhat, if not completely unsustainable.” 

    Gregory noted that, in 2022, the U.S. spent $252 billion on biologics alone. This represents almost half of all pharmaceutical spending. 

    “It’s half of all pharmaceutical spending, but it only accounts for about 2% to 3% of the total prescriptions that are written. So if you think about that, that’s a huge number and it’s growing every year. 

    “The flip side of that is think about biosimilars. Biosimilars are in the market. They’re here to stay. The purpose of biosimilars is to lower health care costs on biosimilars and improve access. So biosimilars are supposed to save the healthcare system $180 billion. I think when biosimilars first came to market, some of the earlier biosimilars did not reflect huge price discounts off of the reference products.

    “If we look at the future of cell and gene therapy products, I think we are barely touching the tip of the iceberg with what we have on the market currently.”

    Fran Gregory, vice president of Emerging Therapies, Cardinal Health 

    “However, in the past year, even in the past six months, we have seen some extremely convincing cost discounts off of reference product prices. Some of the most recent biosimilars that have launched have actually exceeded 85% off of the price of the reference product. Huge discounts that are extremely meaningful not only to the health care system, but ultimately to improving access and creating a more sustainable environment for pharmaceuticals moving forward.” 

    Gregory said this could balance the extremely expensive, innovative products. 

    “From 2024 to 2027, cell and gene therapies will have cost the health care system in the US around $70 billion: $27 billion of that will occur in 2027 alone. These are conservative estimates, assuming that products do get approved as we expect them to get approved and that the FDA indeed holds up their commitment to approving 10 to 20 cell and gene therapies per year over the next couple of years.” 

    Unlocking savings and innovation: The promise of biosimilars

    Gregory said if the US could improve and optimize the uptake and utilization of biosimilars, the $180 billion in savings could fund innovative products coming to market in the cell and gene therapy space. It could also finance other innovative products that might be forthcoming. 

    “For biosimilars, there are a lot of knowns. With biosimilars, we typically know launch dates. We know when patents are going to expire, with some ambiguity, of course. We have some idea of what types of patents would be upheld versus what types of patents might not on certain reference products. 

    “For biosimilars, we are really tracking less clinical development and more patent expiration, more litigation outcomes.” 

    Gregory said litigation is the most difficult to track.

    The company also produces an annual biosimilars report. The report is a look at what’s current in the space, analysis, and a look forward to what may happen in the next year.

    Monitoring the evolution of cell and gene therapy development

    Cell and gene therapy development, because it is so new, is tracked in a different way, Gregory said.

    She said the company follows the industry pipeline very closely. Cardinal Health’s regulatory consulting segment is involved with biotech companies early on in the process to help move products through to commercialization. 

    “The interesting area in this space is investor activity. Many of these small companies are developing maybe one or two cell or gene therapy products. Following the investment activity that is happening around these organizations can also be an early indicator of how these products might fare in the long term.

    “We are involved very early with these manufacturers. Most of these small manufacturers, we know them well, we talk to them often. They need a lot of resources due to the fact that many of them are small.”

    Diversification in cell and gene therapies

    Cell and gene therapies are relatively new, but Gregory sees the space diversifying.

    “I think one of the misnomers that some people might have in the cell and gene therapy space is that they are for oncology. However, we also have several treatments available on the market that are for conditions like hemophilia. There were two products approved in December for sickle cell disease. 

    “So the treatment paradigm is extremely broad and the types of providers that are involved in providing these types of therapies to patients is broad and becoming more broad as we speak. So I think that’s really exciting. I think the most exciting part is that patients who have never had any option for any kind of relief from their disease are finally having hope.

    “If we look at the future of cell and gene therapy products, I think we are barely touching the tip of the iceberg with what we have on the market currently.”

    Allogeneic therapy

    Gregory is enthusiastic about the future of allogeneic therapies. These do not need to source the treatment from the patient. This means that one donor can potentially create a batch of treatments for more than 100 patients. 

    “I think this is where the future really is when we look at cell therapy and gene therapy is being able to create higher volumes of products with fewer patient donors needed. I think not only will that science evolve into that allogeneic space and the gene therapy space, we’ll also see a lot more innovation in manufacturing.” 

    Advanced Therapies Week: the highlights

    Gregory attended the annual Advanced Therapies Week in Miami Beach recently. She said one of the key takeaways was the need for standardization.

    “We really talked a lot throughout the week about the need for standardization versus the custom approach, one patient for one manufacturer for one drug at a time, really standardizing the process so that there’s more scalability and not only scalability in the manufacturer, but also on the provider and the patient experience side. So really a lot of discussion about how do we make this process scalable for health care providers?”

    “The second thing, if I had to kind of group themes, would be the value and access theme. One of the stats that I heard that was very sad was that only two out of 10 eligible U.S. patients actually receive a CAR-T cell therapy, even if they have a need for it and their indication matches that product’s indication.

    “I think the goal for all of us is to make that number 10 out of 10 eligible patients receive the therapy that they need. So I heard a lot about how do we make that happen as an industry working together to get these products to patients.”

    Cardinal Health vision for the future of biotechnology

    As for the future, Gregory said: “Number one would be the continued push on efficiency, manufacturing improvements, and making sure that we get the technology to a place where it’s scalable. That will result in number two, which would be the lowering of prices.

    “I think that that absolutely has to happen in this space. Then the third thing would be we talked about value and access, creating much more clear pharmacoeconomic messages that demonstrate the value, the financial and the clinical value of these products, long-term and short-term. 

    “And then the last thing that I think is probably the most exciting thing is the richness of the pipeline in cell and gene therapy. So, I think we’ll keep on seeing really amazing innovations come into the pipeline.”

    To learn more about this topic

    Here are some links to more articles on the subject of biosimilars and cell and gene therapies.

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