From The Editor | June 25, 2018

"Locally Brilliant": 3 Biosimilar Market Access Experiences

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By Anna Rose Welch, Editor, Biosimilar Development
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When we consider the most important aspects of a partnership between any two pharma companies, there are a few qualities that are universally emphasized, including trust, honesty, and communication. But as I discussed in a previous article, there are four factors — local/national policies, real-world evidence needs, tendering practices, and questions of value — that make a partnership for biosimilar commercialization particularly complex.

As Richard Trollope, commercial head of oncology and biosimilars at Mundipharma International, emphasized, there is one other quality that defines a successful partnership in the biosimilar realm: agility. When you’re working in Europe, which is united in its variability, constant dialogue becomes even more important. The partners need to be clear with each other when something has changed and why differences exist between health systems.

This agility is best showcased through Mundipharma’s successful partnership with Celltrion. As Celltrion’s distribution partner for Remsima (infliximab), Truxima (rituximab), and most recently Herzuma (trastuzumab) in several different EU nations, Mundipharma was a leading player in launching the biosimilar monoclonal antibody market in Europe.

Naturally, this seemed like a great opportunity to pick Trollope’s brain about his learnings from working with these three different biosimilar molecules, as well as the questions that remain — especially about the newly launched Herzuma, which was recently introduced in the U.K. and Germany.

The Infliximab Journey: Reprogramming Dogma

As is to be expected, a large part of Mundipharma’s first biosimilar journey with Remsima was reshaping the many different stakeholders’ perceptions of biosimilars as new chemical entities or generics.

 “With generics, if you were to show up with data that said the product had the same pharmacokinetics, physicians would believe you,” Trollope said. “If it were a new chemical entity, they would ask to see the Phase 3 data proving your candidate was better than the standard of care. When we walked into the market and we had neither, people just brushed it off in disbelief. Celltrion and Mundipharma had to work hard together to get the data requested to persuade healthcare physicians. We were reprogramming dogma.”  

As such, the biggest challenge in launching Remsima was learning how to communicate the need to transition patients from the reference product to the biosimilar. This medical transition had to be communicated, not just between the company to the physician and from the physician to the patient, but also to nurses, hospitals, and other players within the healthcare system.

“We had to make sure the healthcare economy was motivated to make this transition in a sensible, pragmatic way, and then we had to share stakeholders’ successes of how they managed this transition,” he explained. “That didn’t happen overnight, because policies had to be changed and people had to review data on the local level.” As such, Mundipharma’s key account managers were tasked with gathering all the key stakeholders in their specific country in order to come to a multi-stakeholder (magic words) agreement on how this could happen. “You had to have local buy-in and motivation from everybody,” Trollope added. “The payer, the physician, the patient, the nurse all had to come to a consensus, and that’s where the local focus was incredibly important.”

Truxima: Making The Data Fit The Risk Profile

When it came time to launch Truxima, Celltrion’s rituximab biosimilar, Mundipharma was challenged once again by the data package assembled for regulatory approval, especially because of the drug’s risk profile. Being an important treatment for cancer, accepting a biosimilar was a leap of faith given that, if the drug doesn’t work, the patient could die. And when it came to working with physicians to assuage these concerns, the biosimilar didn’t have the clinical evidence they would have expected to see.

As Trollope shared, “The data submitted for the EMA approval was in rheumatoid arthritis and some data in follicular lymphoma. Yet, there was no data for the most deadly of the diseases for which Rituxumab is used: diffuse large B-cell lymphoma. Our clinical data was on the left, but the need for it was on the right.”

The commercial team went back to the education it needed to provide for Remsima — except this time in the oncology space. “We had to teach the market about why the FDA and EMA can approve a medicine based on a theory of extrapolation and what that means,” he added. It was about changing the mindsets of the physicians and encouraging them to ask the right questions and get comfortable with the fact that rituximab was not something new.”

Though the cause of the company’s biggest challenges moving from molecule to molecule was education — one of our favorite terms — the importance of the relationships previously established with key oncology stakeholder groups in each market cannot be underestimated. Trollope pointed out the benefits of those connections (forged prior to the company’s biosimilar work) which enabled earlier conversations about Truxima’s data.

Herzuma: Bridging The Innovation Gap

When Trollope and I spoke, the company had only recently signed on to launch Celltrion’s Herzuma. Indeed, it had only just launched the product in the U.K. and in Germany. So it was a bit too early to speak with certainty about whether any of the strategies learned from Remsima and Truxima will be successful within the Herzuma sphere. The need for education — this time of breast cancer specialists — is a given. However, Trollope hit on another particularly interesting commercial challenge, which is the fact that Roche has had great success with its subcutaneous version of Herceptin.

“Suddenly there are three or four biosimilar players that will be brought to the market this year, none of which have a subcutaneous formulation,” Trollope said. “This raises questions about infusion time and capacity and space that require thinking on a local level. With Herzuma, we have a whole new challenge in front of us as to how we can work with our partners in each country to ensure that the biosimilar is adopted and still fulfills the needs of the healthcare economy.”

And so, we arrive at that tricky question of value, which seems to rear its head more and more often nowadays. As biosimilars hit the market in older formulations, this raises questions about how biosimilar companies can position their products and their value in the face of improved and possibly more convenient or patient-friendly innovator formulations. This will require innovative thinking from biosimilar companies, depending on just how big of a gap was left between the biosimilar and the reference product following that improvement. Naturally, a biosimilar company can rely on the argument that overall lower biosimilar costs will enable the healthcare system to invest in greater treatment capacity or provide access to new medicines. But this also involves some interior soul searching about how a company can try to close the gap between the innovator and the biosimilar.

“You have to ask yourself, ‘What is the convenience that was added, and what was the size of that convenience?’” Trollope offered. “You have to be practical and say, ‘What was it that the subcutaneous formulation solved? Was it financial?’ If so, you’ve got an easy answer. ‘Was it capacity? Was it convenience?’ If those are the answers, you have to find a novel way to fill that gap.”

There are reasonable ways to adjust a product to meet convenience expectations set by the newly formulated innovator. For instance, there are novel ways an IV medicine can be delivered more quickly than normal. Luckily, the innovations we’ve seen so far haven’t created any gaps a biosimilar maker cannot bridge, Trollope pointed out.

Overall, regardless of the candidate, Trollope emphasized the importance of telling a story about how and why this transition into the world of biosimilars can be done. The goal here is to be, as he termed it, “locally brilliant,” and to empower each country. Each healthcare economy has a particular tipping point. For instance, if you look to countries that have been late-comers to biosimilars, like Ireland, there is always a tipping point where a country will find it’s time to start changing its policies. A company then directs its attention to working with those policy makers on the local level to help them understand biosimilars to ensure their product gains adoption in that area.

“We work our way locally on one thing, and then we work our way nationally on another,” said Trollope. “It’s all about tailoring your approach to the healthcare economy and the opportunity that biosimilars offer today — but also preparing for what that might be tomorrow.”