Tony Hagen is senior managing editor for The Center for Biosimilars®.
Christophe Bourdon, senior vice president and general manager of US Oncology for Amgen, discussed the development and marketing plan for the company's newly approved rituximab biosimilar.
The FDA’s approval of Amgen’s rituximab biosimilar (Riabni) this month brings to 29 the number of approved biosimilars in the United States since 2015, and if Amgen launches on schedule in January 2021, there will be 19 marketed biosimilars in total. Amgen has 4 other biosimilars with FDA approvals: adalimumab (Amjevita), infliximab (Avsola), trastuzumab (Kanjinti), and bevacizumab (Mvasi). All are launched except Amjevita (scheduled for 2023).
The Center for Biosimilars® (CfB) interviewed Christophe Bourdon, senior vice president and general manager of US Oncology for Amgen, about the Riabni approval and marketing plan. The product is approved for all indications of the reference product, Rituxan, which in the United States is marketed by Biogen and Genentech and in Europe by Roche. Those indications are non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
Riabni will be launched at a wholesale acquisition cost (WAC) 23.7% less than the reference product, 15.2% less than the WAC for the rituximab biosimilar Truxima, and on par with the WAC for the other rituximab biosimilar, Ruxience. Riabni will be marketed at an average selling price (ASP) 16.7% below the current Rituxan ASP. Ruxience sells for an ASP 20% below Rituxan.
CfB: How long did it take from initial application filing to product approval in the FDA process?
Bourdon: It’s usually 12 months between submission and release, and the good news is we were actually able to get approval 2 days ahead of plan, so we were expecting the Riabni approval on December 19, 2020, and we got it on the 17th.
CfB: What hurdles and challenges did you encounter in terms of gaining approval?
Bourdon: It was a very smooth process. We had some very constructive dialogue—we received feedback and advice from the FDA on the data package, and we’re very pleased to now have the possibility to serve more patients starting early next year.
CfB: Amgen decided to do a comparative clinical efficacy study for Riabni. There’s a lot of debate about whether those are necessary. Was it the FDA that asked you to do that, or was there another reason?
Bourdon: We believe that, for biosimilar approval, generating very solid data is paramount for the safety of patients and also to increase the level of confidence and trust for providers. Riabni was approved here in the United States with a total body of evidence. We submitted comparative analytical, nonclinical, and also clinical data, and at the end we were pleased to see that there were no clinically meaningful differences, both in safety and effectiveness, between Riabni and the rituximab originator.
CfB: So, just to clarify, you feel that having a comparative clinical efficacy study is a big win for gaining confidence of providers and patients?
Bourdon: Exactly. Any data that we can generate to ensure the safety and effectiveness of our product is really something very critical to enhance the trust of providers and also of patients.
CfB: Sometimes biosimilar developers encounter difficulty obtaining originator product samples to facilitate the development work. Did you have any difficulty here?
Bourdon: No, that was not the case. We were really able to obtain sufficient product samples for our needs.
CfB: Have you encountered any litigation with Roche or Genentech over this product, or are you launching “at risk” of litigation?
Bourdon: Amgen has settled all outstanding issues with Genentech and Roche, and we have acquired the license that allows Riabni to be launched within the time frame that we have communicated.
CfB: How much did you have to spend to bring Riabni through the development and approval process to the point of marketing?
Bourdon: Beyond money, we invested time. The Amgen biosimilar journey started 10 years ago, at which time Amgen committed to invest $2 billion in 10 different biosimilar products, so roughly to answer your question, $200 million per biosimilar.
CfB: And $200 million is what you spent on Riabni?
CfB: Are there any particular sales channels you’re aiming for as you roll this product out in the United States?
Bourdon: Our responsibility is to serve every cancer patient here in the United States, so we will make Riabni available for specialty and wholesale distribution as quickly as possible in January—all channels.
CfB: Can you comment on the importance of getting this product placed on formulary—getting both payers and pharmacy benefit managers [PBMs] on board?
Bourdon: Especially in the middle of the pandemic, the financial pressure on the system is really there—it’s tangible. And every stakeholder, whether it’s PBMs, payers, providers, has gained experience over the last 2 to 3 years on how to quickly adopt biosimilars. We have seen, now, payers being very nimble and agile in adopting biosimilars, so we have the experience and we believe we will be able to repeat that success.
CfB: How else will you support the rollout of this product, by educating providers?
Bourdon: We should not forget that, at the end of the day, we’re talking about severely ill cancer patients, and so beyond the economic dimension, providers have a responsibility to have the answers to certain questions. Is it safe to inject or infuse a product? Is the manufacturer a reliable and long-term supplier of the product, ie, guaranteeing there will be no disruption in supply? And certainly, with co-pays and out-of-pocket payments, how can the manufacturer support the patient? This is where we’re really investing a lot of effort, reassuring and informing providers about the role Amgen can play in delivering biosimilars for patients, and I feel very good about this.
CfB: The Amgen 2020 Biosimilar Trends Report noted that rituximab biosimilars have a 20% share of the market relative to Rituxan’s 80%. Do you feel that that 20% share is adequate progress for rituximab biosimilars?
Bourdon: It’s a very fast-moving environment, and if you look at other classes of drugs, we’ve seen fast uptake of biosimilars, so I’m very optimistic and we’re optimistic at Amgen that Riabni will introduce additional benefits.
CfB: Although the first rituximab biosimilar entered market in 2019, Biogen and Genentech have not lowered the price for the originator. Do you feel that the arrival of a third rituximab biosimilar, Riabni, is going to put pressure on them to finally bring down the price on their side?
Bourdon: If you look back 10 years ago, you know that the introduction of biosimilars was really a social compact here in the United States, which was continuing to deliver the best innovative medicines for patients at a lower price, and what we are seeing with the successive launch of biosimilars is 2 things are happening: First, biosimilars are usually introduced at a lower price than originators, bringing short-term savings; and, over time, you see also the originator price (ASP) trending down. These are 2 ways that savings are generated, and we are seeing this across all biosimilars that have been launched so far in the United States. I cannot comment on or predict the future, but Amgen is convinced that the efficiency of the market right now is bringing a lot of savings through price decreases of biosimilars and originators.
CfB: The biosimilar Ruxience is cheaper than Truxima, but Truxima has a higher market share [17% vs 3%]. Would you say this is because Truxima was on the market earlier [November 2019 vs January 2020] or are there other issues here?
Bourdon: It’s complex, between all of the different pricing assumptions. We’ll be launching at a WAC that is below the WAC of the originator, and the WAC does not represent the average selling price, so in the WAC you have no discounts and things like this. I’m absolutely convinced that, over time, we’re going to see an erosion in prices.
CfB: Do you feel that these savings are going to filter down to the health care consumer, ultimately, and provide better access, which is so talked about?
Bourdon: I’m absolutely convinced of that. If you look at what has already happened with the 2 other biosimilars we launched—trastuzumab and bevacizumab—we are seeing a market share improvement getting close to 40% and above, which means that close to 1 out of 2 of these patients are benefiting from cheaper biosimilars, and when you have a declining ASP, it goes directly to reduce the out-of-pocket expense for patients. So, it’s having a positive impact on Medicare patients and commercial payer patients.
CfB: Concluding thoughts?
Bourdon: We’re very excited about Riabni. Some people wonder if biosimilars are working to reduce costs. I think the biosimilar market is working, and as we close the year 2020, it’s important to note that it has been a tough year for health care providers—the frontline workers—and for patients. I think biosimilars are a good solution to bring short-term savings right now so that we can reinvest in discovery in science and for better care of patients.