From The Editor | June 19, 2018

4 Conversations Integral To Building Biosimilar Partnerships

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

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When I sat down with Richard Trollope, commercial head of oncology and biosimilars at Mundipharma International, to talk about the company’s partnership strategies and commercialization experience, I knew we were in for a good conversation when he started out saying, “Anna, can I tell you a story?”

Trollope has been with Mundipharma for almost a decade, and has seen the company establish itself in several different therapeutic areas, including pain management, respiratory and oncology. Biosimilars joined this lineup roughly five years ago, when Mundipharma struck up a successful partnership with biosimilar powerhouse Celltrion. Over the past several years since becoming Celltrion’s distributor for Remsima (infliximab) in Belgium, Germany, Italy, Luxemborg, The Netherlands, and the U.K., Mundipharma also has earned distribution rights to Celltrion’s Truxima (rituximab) and most recently Herzuma (trastuzumab). In early May, Mundipharma announced the launch of Herzuma in Germany and the U.K., with launches anticipated in the other territories (listed above) in the upcoming months.

A common argument I’ve heard many times in the biosimilar market (and, really, throughout pharma, in general) is to know and play to your own strengths. And quite often, this means knowing where you need to rely on a partner to get the best results. What I admire about Mundipharma’s partnership ethic is the company’s emphasis on long-term partnerships. As Trollope shared, Mundipharma strives for partnerships that will last for 10-plus years. Thanks to Trollope, I not only got the inside scoop on what makes a biosimilar partnership specifically a biosimilar partnership (which I’ll cover in this article), but also Mundipharma’s journey in launching Remsima and Truxima (stay tuned!). It’s still too early to tell how these experiences truly will shape the company’s strategies for Herzuma. However, Trollope shares the challenges he expects to face that ultimately speak to an even greater question we’re still fighting to answer in the biosimilar space.    

From day one, this industry has emphasized (and prided itself) on its differences from the small molecule generics market. And, as Trollope said, Mundipharma knew biosimilars were going to be different. It was going to be a whole new challenge to get them embraced in the clinic.

“We knew we were going to have to work with multiple stakeholders — payers, procurement agencies, physician societies and patient advocacy groups — in order to get the product off the shelf and into the clinic,” said Trollope. “We weren’t going to be able to turn up and say, ‘Here, and it’s cheaper than the other one!’ We needed to make sure all of the stakeholders came to a consensus in terms of their positions on biosimilars.”

Now, that’s not to say Mundipharma had a crystal ball and knew exactly how it would all play out. But thanks to Trollope’s background in specialist and primary care in the U.K., he already had relationships in place with the organizations to begin the necessary conversations. It was this background that also helped give him a better sense of what questions needed to be asked about healthcare policies and reimbursement, and who needed to be involved in answering those questions.

There were four big areas he found Mundipharma and Celltrion (and all biosimilar partners) needed to be discussing, especially in the European biosimilar space. Though some of these may be well-established concepts today given the markets’ ongoing progress, several of these topics may still need more attention depending on the territory in which you hope to launch a biosimilar.

The first, no surprise here, is understanding and working to establish policy on the national level — but also especially at the local level. As he aptly put it, the EU is 27 countries “bound together by difference.” Now, there have been great unifying strides lately throughout Europe, thanks to the EMA’s work, and a number of local regulators have become dedicated to implementing biosimilars in countries that once used to be quite skeptical. But as we survey the markets in Europe today, the differing commercial models and policies pose different challenges for companies commercializing biosimilars. It’s in these countries that Trollope emphasizes the importance of “going back to the background.” Narratives about biosimilars being worthy of concern because they were “new” and more appropriate for naïve patients needed to be re-written. “That first step was helping our customers understand what a biological medicine is, much less a biosimilar,” said Trollope.

The second was around sharing real-world evidence, a topic that continues to grow bigger and bigger as more is published on biosimilars’ long-term effects. This meant sharing the success narratives from different local or regional successes within each country. For instance, Trollope pointed out that sharing a specific region’s or hospital’s success with how they integrated biosimilars into their care was and still can be an important step to make others realize that, if it can be done elsewhere, it can certainly be attempted in their own hospital or region. (Though, it’s, of course, important to remember the third major point — tendering practices are quite different, and as such, require extensive knowledge of how to navigate them in the different locales.)      

But the fourth biggest factor the industry needs to continue defining is the motivation for making the switch to biosimilars. This involves answering the question: “what’s in it for me?” As we know, making the switch to a new medication not only can lead to trepidation in patients, but it can also be a hassle for clinics and payers. The goal for a biosimilar company is to ensure it is able to answer the “what’s-in-it-for-me?” question. In some cases, this could mean ensuring a cut of the savings go back into the hospital budget for new employees, supplies, or innovative medicines. But as we go on to discuss in the second part of this article, there are a number of other considerations that need to be made as well — especially when it comes to bridging what he termed “the innovation gap.”

Stay tuned for the second part of this article in which Trollope and I discuss some of the best practices and approaches he’s learned about commercializing biosimilars and establishing their value through the launch of Remsima, Truxima, and Herzuma.