From The Editor | July 31, 2017

How To Handle The Impending Biosimilar Pipeline Boom

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

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For the past few weeks, I’ve been writing a book chapter on the basics of biosimilars for an upcoming industry publication. It wouldn’t be an introductory chapter on biosimilars if I didn’t include brief references to market forecasts and healthcare savings estimates. And, if you’ve spent any time in the biosimilar space (or the pharmaceutical industry as a whole) you’ll know there are an overwhelming number of market forecasts being released almost daily. What is $250 billion in biosimilar healthcare savings to one research company is “only” $40 billion to another. And depending on what year these studies were released, the predictions for the market in 2017 were likely much higher than where we actually stand today.

As Jorge Santos de Silva of McKinsey & Company described in his presentation at the 2017 World Biosimilar Congress, the market predictions being released in the past, as well as today are still quite bullish. But these predictions are being reined in slightly as we grapple with the reality of the market and attempt to get a clearer picture of where we’re headed.

For instance, from 2015 to 2016, the U.S. alone brought in roughly $500 million in biosimilar revenue. This is compared to $1.3 billion in the EU, and $1.2 billion in China. (Important to note, all of these figures include Basaglar, which was approved as a follow-on biologic, rather than a biosimilar.) In de Silva’s opinion, the biosimilar opportunity is still a major market opportunity even though it hasn’t yet lived up to greater estimations. He predicts the global biosimilar market, sales of which are valued at $5 billion, will double or triple by 2020.

In fact, recent financial reports suggest biosimilar sales and adoption rates are on the rise. If we look at Biogen’s most recent quarterly update, the company’s Enbrel and Remicade biosimilars (in partnership with Samsung Bioepis) experienced 490 percent growth in the last year alone (and it’s actually been less than a year). The company’s biosimilar sales of Remicade and Enbrel in the EU jumped from $15 million in Q2’16 to $66 million in Q1’17. In Q2’17, this total jumped to $91 million. But even more importantly, I’ve heard through the grapevine that more than 50,000 patients have been able to receive these cheaper biologic treatments. Benepali even has its own hashtag on Instagram. (If you have an Instagram account, I’d urge you to take a peek. Though you’ll need to translate some Swedish and Dutch, you will see first-hand the happiness of patients, as well as some of the anxiety you can expect from those who are switching and asking for good thoughts.)

In addition to these positive reports, de Silva also drew attention to the diverse biosimilar market frameworks being established in emerging markets, such as Brazil, as well as increasing comfort with switching and extrapolation. But taking advantage of these market opportunities will require greater-than-expected work on the commercialization front. Indeed, as biosimilars occupy the grey area between innovator and generic, companies need to adopt the appropriate commercial model and consider how the development process can evolve to ensure quicker and more affordable patient access.

As de Silva described, “Market forecasts are complicated by the fact there is no linear growth, which can be exemplified by the varying degrees of infliximab uptake — even after a few years on the market. Many of the incoming players had to adjust their commercial models in the beginning. This goes to show the growth of the biosimilar market requires a lot of understanding of the granularity of the $5 to $10 billion growth of the market in the years ahead.” 

There is, obviously, no cut-and-dried approach to launching a biosimilar (or any drug) globally. It comes down to having, as de Silva listed, the “right commercial model for the right product in the right channel in the right market.” But knowing what is “right” when there is no one-size-fits-all aspect to launching a product in multiple nations can be a particular stumbling block for many companies. (In fact, some biosimilar-hopeful companies are even going to have to learn how to successfully launch biologics, as there are quite a few without that experience.)

“You will need to have different discussions with different stakeholders, and handling all these conversations will place a lot of pressure on the marketing, sales, and operations within the business,” de Silva described. “Perhaps we weren’t anticipating pressure on these particular parts of the business, but this means that, moving forward, we need to alleviate pressures from other parts of the development model.” 

By de Silva’s estimate, the biosimilar industry will need to “brace for impact” because of how active the biosimilar pipeline will be from 2019 to 2021. Up to this point, the industry has been talking about and releasing real-world data on the autoimmune Anti-TNF blockbusters in particular. But the European Medicines Agency (EMA) and the FDA have already approved (or moved to approve) biosimilars of Avastin, Herceptin, and Rituxan. These oncology products are part of a therapeutic area that de Silva argues is changing much more dramatically than the autoimmune space, especially if we think about the leaps being made on innovative immunotherapies and combination drugs.

Given the complexity of the oncology pipeline, de Silva argued in favor of reducing some of the demands of current biosimilar development. We’re all familiar by now with the FDA’s inverted biosimilar development triangle, in which human clinical studies make up the small peak of the triangle. It’s also becoming more common to hear discussions in the industry about  reducing clinical trial requirements or eliminating them altogether in favor of analytics and real-world evidence. This would not only lower overall development costs for biosimilars, but these efforts would also ease the burden of recruiting patients for large Phase 3 clinical trials — especially when it comes to more complicated oncological indications and rare diseases.  

De Silva put it best when he asked “Is there a world in which we can start narrowing the clinical side of the inverted development pyramid? Can we go from $150 million for development of a single molecule to $50 million, especially if biosimilar makers have to do a lot of commercial work?”