It has been a busy year for biosimilars at Biogen, starting early in the year with with the sale of its stake in Samsung Bioepis. During Global Biosimilars Week, we interviewed Ian Henshaw, Biogen’s Senior Vice President and Global Head of Biosimilars, to get his perspectives on what the coming year has in store.
BR&R: What is your perception today of the state of the U.S. biosimilar industry, and how does it compare with the biosimilar industry in the European Union?
Henshaw: It’s clear that the U.S. biosimilars business is catching up and accelerating, particularly with the launches of the three oncolytics—rituximab, trastuzumab, bevacizumab. We’re starting to see health care systems become more organized towards the potential of biosimilars to save money, increase patient access, or improve the quality of care for patients. That is exciting and good for U.S. patients, good for the U.S. health care systems, and they are catching up with Europe.
BR&R: It’s particularly exciting now, as we head into 2023 and the launches of adalimumab biosimilars. OptumRx just announced their decision that Humira® will not be the only choice of adalimumab, that up to 3 biosimilars will be at parity with the reference product. Other major pharmacy benefit managers and other U.S. payers will be revealing their decisions in the next few weeks, at least hinting at which biosimilars or how many will be covered.
Henshaw: Yes, I completely agree. Biosimilars of Humira in the United States is another chapter within the “book of biosimilars.” We look forward to seeing what happens there.
BR&R: What was Biogen’s experience with EU launch of adalimumab biosimilars in 2018?
Henshaw: Well, three biosimilars were launched on nearly the same day, and then two or three biosimilars were added within six months. It was very competitive from day 1. In terms of commercialization processes, we had to deal with several different types, as you well understand. Some markets started with contracts, some with tenders, and pricing and reimbursement activities had to start at that point. Of course, a lot of additional customer interaction was involved, particularly with pharmacists, physicians, and payers. This created a whole new level of excitement within Europe. Within a short period of time, the total number of patients being treated with the molecule, innovator plus biosimilars, had grown significantly.
BR&R: Fast forward to 2022. Has the number of manufacturers competing with adalimumab biosimilars dropped off? Or has each competitor attained a sustainable marketshare?
Henshaw: That’s a good question. First, we should go back a couple of steps and ask, “who has developed through to phase 3 trials?” and then, “who has filed for approval?” The answer is that not every manufacturer has filed in Europe. For those attaining approval and launching, you’ll see that all entrants have generally made progress. It is time dependent though; the ones there at the beginning are probably achieving the better results.
Global Biosimilars Week
BR&R: [Last week closed] the 2023 Global Biosimilars Week. Why do you think it is important that the Global Biosimilars Week efforts and Biogen’s support of it continue? What do you think is the strongest attribute of Global Biosimilars Week?
Henshaw: With an aging population and the COVID-19 pandemic slowly receding into the past, biosimilars offer a key to unlock the potential for patients who need the specific pharmaceuticals in question and/or treatments that are innovative and new. You get a great dynamic when biosimilars are added to the availability of biologics or advanced biologics. That’s point number 1.
Point number 2: If you break it down into the competition piece, the stakeholders probably settle first on what they can save in terms of health care costs, which, of course, is what you hear. Then it transitions very nicely into increased access, as we’ve seen widely across Europe, which is a great thing.
Point number 3: You see very good case studies where, adding in additional resources or education and services, you obtain a much higher patient quality of care or pathway of care.
These three—savings, increased access, and the quality of care—result in the big win here.
BR&R: Where do you think is our biggest gap in terms of biosimilar understanding and adoption in the United States?
Henshaw: First of all, there’s still, in some therapeutic areas, the question around the quality of biosimilars. This is not new, but perhaps at a different stage. The questions around efficacy and safety have been fully qualified by the regulators, generally.
Then you get to the point of uptake. Are biosimilars for treatment-naïve patients only? Or for patients who are established on reference drug therapy? What is the process?
Dare I say that the reimbursement of some of the drugs, whether through buy-and-bill and/or Medicare part B, in most cases that we’ve seen, is something that needs to be worked through in terms of insurance parity coverage.
Adalimumab will be the first major product to be reimbursed through part D. As mentioned earlier, we look at that as a new chapter. That’s where you’ll start to see that speed up, once the second and third part D biosimilar products are approved. There is still some learning for systems across payers, PBMs, and the government organizations.
BR&R: From a regulatory and legislative standpoint, what steps still need to be taken to enable the biosimilar industry to flourish?
Henshaw: The regulators have an important job: They ensure comparability between the biosimilar and the innovator. As we progress, we’re looking more at how biosimilars compare relative to each other. The majority of that analysis continues to be in the early technical proof of biosimilarity and the body of evidence that is done in the technical and process piece. It is supported by phase 1 pharmacokinetic and pharmacodynamic studies. The ongoing debate at the moment is about the future need for phase 3 data. I believe that if you reduce the need for phase 3 data, you remove time from the development process and you potentially increase competition. With that, you may have a different scenario at some point in the future.
BR&R: How do we make that happen?
Henshaw: You have to dialogue with the regulatory bodies directly about what is important and to establish comparability as part of the biosimilar package. That is where industry, as a whole, can help lead the discussion.
Biogen’s Biosimilar Path Going Forward
BR&R: Biogen has deep roots in biosimilar development, especially considering its long joint venture with Samsung Biologics in Samsung Bioepis. Biogen sold the equity stake in Samsung Bioepis in January—did that signal a change in direction for Biogen on biosimilars?
Henshaw: The joint venture, Samsung Bioepis, successfully brought to market six or seven different products in the last 10 years. That’s great news. We have commercialization rights for five of those ourselves. We continue to support and commercialize that aspect of the business.
Both Samsung Biologics and Biogen joined with the same intent, and that intent continues to bring more biosimilars to the marketplace. As you will see from our pipeline, we also secured a biosimilar of Actemra® and a biosimilar of Cimzia® around the same period. At Biogen, we will continue that journey, continue to unlock the potential which we believe in, and continue to transform more lives across the therapeutic index.
BR&R: Several of the biopharmaceutical companies, like Amgen, Pfizer, and Biogen, produce both reference products and biosimilars. How does Biogen straddle that balance?
Henshaw: Societally, there’s treating patients with advanced biologics whether they are an innovator or any original form, and then making those advanced biologics as biosimilars is in fact the same intent. You have a scenario, which we have seen around the world and particularly in Europe, where you have savings generated from biosimilars, and that creates headroom for additional patients to be served within that particular therapeutic area. It also creates headroom for the new, innovative products that we have in our pipeline or just brought to market.
That is actually a very good balance to bring to the health care systems, as we consider aging populations, more demands, higher health care expenditure generally.
Like the other companies you mentioned, Biogen has that ability to apply not only that in terms of commercialization and intent but also to deploy our parentage or experience—in our case, 40- plus years of biologics, manufacturing, and technology. I think that is where you start to see synergies.
BR&R: Straddling that balance also optimizing the lifecycle of reference products. For instance, Sandoz is trying to introduce a biosimilar for natalizumab for multiple sclerosis, and unsurprisingly, Biogen recently filed patent litigation to delay the launch. The push–pull balance of these companies who are developing biosimilars and reference drugs fascinates me. The intellectual property aspect of a reference manufacturer doesn’t mesh well with biosimilar commercialization.
Henshaw: It is about balance, as you covered here. We cannot comment on ongoing regulatory reviews or litigation.
BR&R: Let’s go back to one specific area you mentioned: Biogen’s acquisition of the rights for a Cimzia® biosimilar. Cimzia has been around for quite some time, without biosimilar competition (perhaps due to the difficulty to manufacture it and a patent thicket from UCB). We cannot find publicly available information from another manufacturer who intends to produce a biosimilar for Cimzia.
How does Biogen actually view the opportunity with a product like Cimzia?
Henshaw: I think you make a good point with Cimzia. There are probably undeclared developers on this product, so that will continue to evolve. The process and the technology associated with it is advanced, and I think Biogen, with its heritage, can apply some of its insight there. That’s where it comes through. At the end of the day, whether it is a Cimzia biosimilar or others that are coming, or past and present, they all have the same impact.
There are biologics out there that may not make the threshold for development: pediatric, orphan drugs, etc. There may not be enough revenue to turn them into a profitable or sustainable biosimilar business. That’s where we should be focusing our debate, again, referencing some of the pathways and partnerships that need to happen.
Today, we see a lot of focus by the major players on the same products, but you won’t have that same focus across the spectrum of biologics that have been approved for use and may be eligible candidates for biosimilar development. So, you get this “crowding” situation.
The great news is, with Biosimilars Week, there are 600 biosimilars that have been approved across the world, but if you then look at the 89 that are approved in Europe, they are only from 19 molecules. Have we had a good start on some products and are we learning a lot? Yes, we are. Is there more to go in terms of time and efficiencies and partnership in this space? Yes.
I get hopeful particularly for what it will do in terms of increasing patient access as well as savings. But the greater the access, the better the quality of care.
BR&R: I’m going to pin you down. Three years from now, how many approved biosimilars will available for use in the United States?
Henshaw: I would answer in terms of different molecules as opposed to approved products. I think in 10 years you’ll be knocking 40, but let me be distinct: that’s not total number of approvals. That’s different variations of it.
BR&R: Right. Well, that’s fairly encouraging.
Henshaw: And it’s good for humanity.