At the end of last year, Scott Gottlieb, commissioner of the US Food and Drug Administration (FDA), released guidance documents to increase competition within the biologic space.
The guidance confirmed that insulin will be provided biologic designation, which will open a pathway for biosimilars to gain entry onto the market.
The ‘watershed moment’ should see an increase in competition in an area where health care spending is $330bn (€291bn) annually, noted the FDA.
In Europe, the first insulin biosimilar was approved in 2014 and a study found that biosimilars approved in the region were priced 10-35% lower than their reference product.
However, in the UK, diabetologists have recommended that only new patients be treated with insulin biosimilars due to the incompatibility of delivery through reference product devices. This recommendation can create difficulties in achieving a portion of market share in a condition that requires lifelong treatment.
However, this has not stopped market entry of further biosimilars and shortly after the announcement from the FDA, Sandoz revealed that it had signed a commercialisation and supply agreement with Chinese insulin producer, Gan and Lee.
BioPharma-Reporter (BPR) spoke to Stefan Hendriks (SH), global head of biopharmaceuticals at Sandoz, about the partnership and what the introduction of insulin biosimilars will mean for the US market.
BPR: Why has Sandoz developed a position in the insulin biosimilar market?
SH: We are the leader in the biosimilar space, right now, with eight approved products in Europe across oncology, immunology, and endocrinology. There is a huge unmet need in the insulin and diabetes space. There are over 400 million people that have diabetes worldwide, a number which is growing. If you look at the diabetes healthcare expenditure, it is over 12% of the total healthcare expenditure that is going into diabetes and the World Health Organization has also made it a priority. These expenditures and issues are going to increase into the future.
What has recently been reported, and was quoted by the FDA and by the ADA, is that in the US, a lot of patients with diabetes cannot afford their insulin and are not taking it according to the guidance they get from their prescriber. This puts them at risk for complications, blindness, cardiovascular disease, kidney disease, etc. So, we really feel that patients need a team that fights for them, we really feel that Sandoz is well positioned to do so as an established leader in biosimilars.
BPR: How have regulations changed to allow for insulin biosimilars to be introduced?
SH: In 2020, in the US, the regulatory pathway will change for biosimilars – that is an important moment. Insulins are mature products and they were approved before there was a pathway for biologics in the US. In March 2020, insulins will be seen as biologics and that allows us to file via the regular biosimilar similar pathway. That makes a big difference because, right now, technically, it's impossible to submit a biosimilar for insulin in the US.
BPR: How did Sandoz’s partnership with Gan and Lee develop?
SH: We looked for a partner that would best fit our strategic approach and Gan and Lee has 20 years of experience in the insulin space. As the main player in China, it has the capacity to manufacture the volumes we anticipate as necessary for the market. We, on the other hand, have the credibility and the presence in the market with eight biosimilars already approved and an effective commercial footprint. So, we are a really good match.
BPR: What timeframe are you looking at for approval of pipeline products?
SH: The products we are developing are still in the early stage so I cannot give you a clear timeline yet. As soon as we are ready with the development and the data, we will submit as soon as possible after. We have one compound going into Phase III, and there are others that are little bit earlier.
BPR: Very little has been heard on insulin biosimilar developments in the US, is there a reason for that?
SH: Well, first of all, there's not a lot of players that have gone in this space. My speculation would be that not a lot of players will have the capacity to manufacture the volume of product that is needed. Secondly, it's a huge market with a lot of patients, and a lot of patients that are not yet getting insulin or are not taking their insulin because they cannot afford it.
BPR: What will be the impact of biosimilar introduction to the US insulin market?
SH: We believe the impact of biosimilar introduction will be significant because the market is so large. When you introduce a biosimilar and you create that competitiveness then prices will go down, which is good for patients and for the healthcare system. As a consequence of that, more patients will be able to afford to use their insulin or will get insulin – meaning millions more patients will be treated.
BPR: Geographically, how will you expand access? How do you see the major market evolving at the moment?
SH: Clearly, US and Europe have a priority, but we will go broadly as fast as we can. We are positive about the evolution of the US market, I fundamentally cannot imagine the market without biosimilars. The reference product, they need a challenger and the market needs that competition. That's why currently in the US you see different stakeholders collaborating, with momentum being built in different places to create that competitive marketplace that is more welcoming for biosimilars.
In Europe, we clearly see strong biosimilar acceleration, much faster than we anticipated. Confirmed together with recent launches, we also see the acceptance and a willingness to switch to biosimilars in Europe is very positive and growing.
BPR: Why has the US been slower to adopt biosimilars compared to Europe?
SH: The European market for biosimilars was clearly a success, they were the first to adopt and, now, the application process goes very quickly. The way I look at the US market is that it's delayed but it's accelerating. We have a number of products approved in the US and most of them have been approved in the last 18 months, some of them very recently. You can clearly see an acceleration from a regulatory perspective. The FDA has put in place some really good plans and good intentions to improve access – you also see other stakeholders playing a role. So, we are positive about the evolution of the US market.
BPR: The UK recently ensured that all biosimilars for Humira found a place on the market. How necessary is this type of tender process?
SH: You see some examples where national tenders chose to stick with the originator because of the binary nature of the national tender process and the rebate. They wanted to avoid the hassle and stayed with the originator product. However, if they do that then they're not creating a sustainable marketplace for biosimilars. As we saw in the UK with Humira, we can deliver on the promise of biosimilars for patient access and sustainable healthcare systems when we work together, and fair practices are in place – such as multiple allotments and/or multi-sourcing tender structures.
Stefan Hendriks is head of biopharmaceuticals at Sandoz. He has held this position for 10 months, prior to this he worked at Bristol-Myers Squibb for over 15 years and at AstraZeneca for eight years.