We first met Thomas Nusbickel in 2014 when he was Hospira’s Head of US Market Access and involved with the commercialization of Hospira’s Retacrit®, slated at the time to become one of the first biosimilars approved by the FDA. Tom went on to a distinguished career in biosimilars, and he is currently leading the effort to build a US salesforce for Celltrion USA.
Biosimilars Review & Report: Tom, you’ve been in the biosimilar manufacturing industry a long time. Since your early experience at Hospira, how has your interaction changed over time (1) with payers and (2) with your own sales teams?
Thomas Nusbickel: Things have evolved quite a bit since I was working on a biosimilar for Epogen® and Procrit®. At that point, we weren’t sure how aggressively payers would control the medical benefit. We saw that occur first with the introduction of Inflectra® and then with the monoclonal antibodies for the treatment of cancer. We are seeing increasingly aggressive management from payers, even on the medical benefit.
As an industry, we were successful in changing some of the early rules that the Centers for Medicare and Medicaid Services (CMS) had put in place. When we were working on Retacrit®, CMS was planning to use blended Q or J codes, which would’ve been very damaging for the survival of biosimilars. It would have created a huge advantage for the originators.
Since then, CMS has implemented some changes favoring biosimilar use. We’ve also seen a number of different ways the originator companies have defended their marketshare, including the aggressive defense of Remicade® [by Janssen] and more of a “let’s go ahead and just move on to other products” approach [by Genentech-Roche antibodies in cancer]. We saw Amgen aggressively defend Neulasta®, first with Onpro® but also with pretty aggressive discounting.
We’ve seen a pattern of how the oncology market and the buy-and-bill markets have changed, and learned what you need to do to balance your provider and your payer rebates and try to be as sustainable as possible over time. On April 10, we launched Vegzelma®, our bevacizumab biosimilar, and things are going well for us.
BR&R: What about on the pharmacy benefit side?
Nusbickel: We haven’t yet seen how aggressively payers will manage a pharmacy benefit biosimilar, despite the launch of adalimumab biosimilars in January. Celltrion will be introducing two biosimilars for the immunology market that will be covered under the pharmacy benefit—Yuflyma® (adalimumab) and an ustekinumab biosimilar. Yuflyma will be launched in July.
Celltrion will also be introducing what we used to call a “bio-better,” our infliximab subcutaneous formulation, which was filed last year as a 351(a) biologic product, not as a biosimilar. We expect that this may be covered on both the medical and the pharmacy benefit side, as some patients will need to visit the physician office to receive their injection. [Editor’s Note: Based on a Q4 2022 filing, an FDA decision should be expected in Q4 2023].
Why Build a US Sales Team? Why Now?
BR&R: Celltrion is heavily invested in its biosimilar pipeline, including candidates for a number of high-profile biologics (like Eylea, Stelara, and Prolia). How great a factor was this in the decision to seek an in-house sales team for the US?
Nusbickel: Yes. The founder of Celltrion, who just recently returned as chairman, was evaluating the company’s growth and growth potential. He looked at where we needed to be most successful. And that was the US market, which is the largest global market.
We’ll be launching these 3 new biosimilars and the new subcutaneous formulation of infliximab in late 2023 or 2024, and we’ll have 11 products on the market by the end of 2025. Based on this growth, the company decided to build its own direct sales capability in the US.
I’ve built my team based on the capabilities that I knew that we needed to be successful with biosimilars. The critical functions we needed to establish included understanding the customer and payer data, being able to segment the various markets and decide where we’re going to play, and choosing how to manage average sales prices, rebates, and discounts to providers and payers.
For the oncology market, we decided to find really experienced, successful oncology salespeople. We put a small team out in the field. The early results are encouraging, and we’ve been introducing Celltrion to this new market segment.
BR&R: When you’re building a biosimilar accounts team, how does that differ, if at all, from building a team for a new brand?
Nusbickel: There’s a different capability. Biosimilars are pretty well accepted today by oncologists, so you’re not selling clinically at all. You have a medical affairs department that can address any medical questions. Instead, you’re looking for people who understand the individual customer and can close contracts.
With immunology biosimilars, many of the physician specialties have less familiarity than they have with oncology biosimilars. As a result, we’ll need to significantly educate providers and patients. For both brand drugs and biosimilars, it is important that the customer-facing person understands access and patient services to make sure that a patient and a customer can access the drug with minimal burden at an affordable cost. It’s extremely important to invest in the right salespeople who are trained to problem solve customer access challenges.
BR&R: Have you been prioritizing biosimilar experience when hiring for your team, or are you educating them about biosimilars once they are on board?
Nusbickel: On the oncology side, we had a mix of both. A lot of people have started selling therapeutic oncology drugs, but all except maybe one had some experience with biosimilars.
There aren’t many immunology biosimilars out there today. So, we seek reps who have relationships with the large practices, the customers, and also have some familiarity with selling in this arena.
BR&R: How steep is that learning curve?
Nusbickel: It’s teachable, but with oncology, we had a more limited amount of time to build a team. We wanted people who didn’t need too much training.
If a drug has been on the market for a couple of years and has faced competition, salespeople will be mostly dealing with the following general questions: What does the payer coverage look like? Can a patient access the drug? What’s the copay? In the last 10 years, those types of market access issues have generally become more important parts of how a sales rep sells. The clinical sell, obviously, is still important in some areas, but you need to have good market-access skills.
People who have a good sales record in the immunology sector, selling Enbrel®, Humira®, and some of the other competitor drugs, certainly have a leg up in terms of our interest. We can teach the biosimilar access piece of it, particularly because this will not be, for the most part, a contracted situation. The contract is with the pharmacy benefit manager or with the integrated delivery network.
BR&R: You’ve mentioned one significant previous challenge, rapidly developing the field force. Are there any environmental factors working in your favor to help you assemble the talent you need, from the ground up?
Nusbickel: We’ve been making good progress finding good people and getting them hired. On the other hand, the originator companies have been reducing their sales forces, because their drugs are going off patent and encountering biosimilar competition. The combination of Celltrion having an exciting pipeline and the originator’s revenue forecasts has made it possible for us to find talented personnel and bring them on board.
BR&R: What do you think is the right size for Celltrion’s salesforce?
Nusbickel: Before we know that, we’ll need to see where we get Yuflyma coverage. We’ve made our bids for 2023, and we’re still in the running with the formularies for the three large PBMs, for some of the smaller plans, and then some IDNs as well.
We’re calculating how many people we would need if we were able to access 100% of the business, and where we would place them. At this time, most of the PBMs have been slow walking their formulary coverage decisions, and we probably won’t have a good idea until very close to July 1, when we intend to launch Yuflyma. We wouldn’t put people out there in a specific geographic area selling Yuflyma if we don’t have access to a major number of lives there.
The other consideration is the infliximab subcutaneous launch, coming in the first quarter of next year. We need to establish relationships with these key customers and confidence in Celltrion first to be successful in marketing our products.
The Pfizer–Celltrion Marketing Agreement
BR&R: Celltrion has a long-standing agreement with Pfizer for the marketing of Inflectra®. Will plans to introduce Celltrion’s own salesforce affect that agreement?
Nusbickel: Not immediately. This is the type of thing that we will continuously assess with our partners over the next few years.
BR&R: Well, the launch of the subcutaneous formulation of infliximab begs a very interesting question: You’ll be directly competing with Pfizer on the infusible form (Inflectra). That’s going to be an interesting situation.
Nusbickel: We are in the field speaking with customer groups to determine where they see the most promise for our subcutaneous formulation of infliximab.
Where Will the Adalimumab Market be in 2025?
BR&R: Your other point is well taken, Tom. The biosimilar adalimumab launch situation is extraordinarily dynamic right now. July 1 won’t tell you an awful lot about 2024. It will only tell you about what’s happened up to July 1, 2023, which isn’t much. Many decisions will have to be made on the fly, adjusting and readjusting to the situation at hand, while planning for the next round of contracting. Do you view this time as really setting your company up for success in 2024?
Nusbickel: Yes, and not even just 2024; we are playing the long game with our pipeline products. From now through 2030, I want to have a sustainable organization that’s profitable, building for the future, and continuing to be one of the leading biosimilar companies in the marketplace.
The PBMs have not said publicly when they are likely to delete Humira from their formularies. It is unlikely to happen until the end of 2024. We want to do well with Yuflyma at that time while also building good relationships in preparation for the launch of our next two immunology products and the unique infliximab formulation.
BR&R: Give me your best guess: How many manufacturers will remain in the adalimumab competition in late 2025?
Nusbickel: I’d probably say it’ll be down to four or five. There could be some consolidation, but I can’t see a lot of companies sitting there with a 5% marketshare. It will likely shake out to be four main competitors.
I believe that if some changes can be made to how the pharmacy benefit market works, we can get more biosimilars and have them be more sustainable. The way it stands now, this will be a challenging business, at least until the plans start restricting Humira from the formulary.
BR&R: Tom, what would you say are the most important lessons you’ve learned over the course of your career in commercializing biosimilars?
Nusbickel: Listen to the customers on both the access and the sales side and really make sure that you can align your company perspective as to where you want to play and how you will win. These are the very basic strategic questions that need to be addressed. Choose your spots, be comfortable with your decisions, and don’t go for everything. Make sure that you build a very nimble decision-making process because these markets move much quicker than the brand markets. You need to be able to respond quickly to be successful.