From The Editor | November 5, 2018

U.S. Biosimilar Progress: Are We Getting Ahead Of Ourselves?

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By Anna Rose Welch, Editor, Biosimilar Development
Follow Me On Twitter @AnnaRoseWelch

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In a recent article, Chrys Kokino, the head of biologics and insulins for Mylan North America, shared the steps Mylan took to get its pegfilgrastim biosimilar, Fulphila, up and running in the U.S. market. I was unceasingly curious about which conversations needed to happen to establish Fulphila’s launch strategy — especially following all pegfilgrastim biosimilars’ regulatory hurdles. After all, establishing a product in the U.S. biosimilar market today is no mean feat. While Europe moves away from the industry building blocks to discussions on long-term sustainability, the U.S. continues to juggle the basics. We remain caught up in the education of multiple stakeholders; the establishment of fitting policies, prices, vendor contracts, and legal settlements; and the exhausting tango through existing patent thickets.

In light of all of these aspects, I wanted to get Kokino’s perspectives on the U.S. market. He, too, has found himself surprised at the slow spread of knowledge about biosimilars thus far. For those of us immersed in daily biosimilar conversations and strategy development, it may feel as though we’re finally making some headway. We’ve laid a fairly broad foundation thanks to regulators’ and companies’ efforts to launch biosimilar education initiatives. That’s why Kokino was stunned to find that, at a recent conference comprising upwards of 500 to 600 people, a large segment of that population still didn’t know about the regulatory process for biosimilars or whether any biosimilars had launched outside of the U.S. (LOL.)

Similarly, I was somewhat distressed to read a recent article revealing just how much of a gap remains in the world of physicians. A survey of 1,536 specialty physicians across all therapeutic areas revealed 61 percent of respondents believe biosimilars have different efficacy than their reference products. As if to strike down my joy over the lack of discussion about extrapolation at the Part 15 FDA hearing a few weeks ago, it turns out 77 percent of the physicians surveyed also did not understand the concept of biosimilar extrapolation. (Insert row of grimacing emoji faces here.)

Perhaps you can understand, then, my line of questioning surrounding Kokino’s thoughts on where the biosimilar market stands today. But rather than focusing on whether the market has a solid basis to survive, he presented some interesting perspectives on the need for a more measured perspective on the market’s financial growth, as well as on the current role of biosimilar competition and differentiation.

Recalibrating Our Ideas Of Success And Failure

When I asked Kokino how he feels about the U.S. market today compared to two years ago, as well as how optimistic he is about the future, he laughed and said that’s a loaded question. (Isn’t that the truth?) But he claimed he is forever the optimist. Making sure biosimilars become mainstream in all the different treatment paradigms will, in some cases, be driven by guidelines from the professional societies in oncology or rheumatology. In turn, these guidelines will emphasize safety and efficacy for academics and clinicians.

But he also argues we’ve come further than we give ourselves credit for. There is still, of course, a long way to go before these treatments become standard in the U.S. But, as he pointed out, the past three years have been filled with conversations and evolutions. “I don’t think it’s fair to draw any parallels of what we’re facing today with what may happen in the future,” he shared. After all, conversations throughout 2017 included, for example, the industry’s concerns about the blended J-code policy. A few months later, however, CMS revealed its policy shift granting biosimilars their own J-codes. Examples such as this and the FDA’s recently released Biosimilar Action Plan (BAP) have reinforced Kokino’s optimism that we’re in the midst of a “living and continuously evolving” market. “I don’t know if the concerns we have about policies or market feasibility will actually hold true six months from now,” said Kokino.

One aspect that does concern him, however, is fixation on the slow financial gains we’ve seen thus far in the market. The originator products on the market today have been built up over decades and have evolved into $5 billion to $6 billion markets — and, in the case of Humira, even more. Comparatively, a biosimilar today may have garnered only $50 million to $100 million of those large markets. To those looking at these totals from the outside, this is a disappointing figure and could signal the market’s failure. But for those who are inside that biosimilar company, any growth is important, as it signals increased market acceptance and greater comfort with the use, uptake, and access of biosimilars as a viable treatment option. “People need to recalibrate their reference points to understand that market-building takes time,” Kokino said.

Are Companies Letting Competition And Differentiation Get The Better Of Them?

A few months ago, I had a great conversation with an expert from Mundipharma, which commercialized a number of Celltrion’s biosimilars throughout Europe. During our conversation, he shared the different paths the company needed to take to commercialize Celltrion’s Remsima, Truxima, and, most recently, Herzuma in certain EU markets. At the time of the conversation, Herzuma was only just beginning to take root in the U.K. and Germany. But one of the biggest questions surrounding the performance of the molecule was the impact of the “innovation gap” between the biosimilar and its innovator. Roche’s subcutaneous version of Herceptin has proven to be a success, and the biosimilars currently hitting the market are in the older, intravenous administration form.

Much like Roche with Herceptin, Amgen has seen success with its Neulasta OnPro, an on-body system which enables the patient to administer the second necessary dose of Neulasta at home the day after chemo. (Without said-system, the patient would need to return to the hospital the day after chemo for their second dose.) As such, I was curious to know whether the OnPro version was a concern to those at Mylan, whose Fulphila is currently only available in the prefilled syringe form.

According to Kokino, the enhanced version of Neulasta was on Mylan’s radar when it was developing Fulphila. But given Mylan’s global presence, there was an interest in introducing a product that would meet the immediate needs of improving patient access in multiple markets. “Neulasta OnPro has a place in the U.S. market for sure, but we’re also looking at other countries around the world where OnPro may not yet be available,” he said. (It’s important to note, the OnPro system was only just approved in May 2018 for the EU market.) “Our initial focus has been to improve access to those patients who may be receiving treatment via the pre-filled syringe route of administration. We are still getting a lot of demand for our product because physicians are excited to finally see competition in this space.”

Of course, Mylan established the same patient services, or “hub services” as the originator — for example, benefits verification and patient assistance programs. “We don’t want to see providers run into any issues in the U.S., for instance, when it comes to benefit verification, product reimbursement or other patient support materials such as copay cards,” Kokino explained. The goal of establishing a seamless patient and provider service has thus far been achieved by building a support system that’s as close as possible to the originator product’s.

In fact, he also argued the biosimilar industry — especially in the U.S. — may be getting ahead of itself when it comes to innovation and differentiation. “We as an industry should be starting with conversations about what patients’ true needs are as opposed to what we’ve done in the past, where manufacturers create all these great materials they think look good, but that nobody uses because they can’t understand them or they’re not appropriately targeted to the right audience,” he offered. In fact, he sees a future in which patient organizations and biosimilar companies are more tightly knit to the point the patient organizations endorse the products or company’s efforts so there is a mutual support structure.

This mutual support also extends from company to company. The industry as a whole has made many strides when negotiating the necessary policies. The trade organizations and individual companies have made wholehearted efforts to share their collective viewpoints on the need for a successful biosimilar industry and a feasible regulatory and pricing environment. But as each individual company strives to be one of several successful players in a competitive biosimilar market, there are, naturally, conversations about how companies can and will differentiate their biosimilar products. Already, Kokino said he’s heard nuanced arguments from manufacturers about how their biosimilars will be better than the reference product. At this point, these kinds of messages are detrimental to the biosimilar industry because, not only do they detract from the overall collective voice the industry needs to have to establish a solid clinical foundation of use for biosimilars, but these types of messages can also lead to confusion.

“We’re not at the point where we can and should be making these arguments yet,” he argued. “We first have to build a foundation where these products are recognized as highly similar to the reference products and should be considered as viable treatment options. We need to speak with one collective voice about safety and efficacy; then we can start talking about differentiating. Otherwise, we just get into these circular discussions and arguments, and we do no good to the industry as a whole. Let’s first build a foundation. Then we can worry about all the bells and whistles later on.”