A few weeks ago, I had the pleasure of speaking with Carol Lynch, chair of the Biosimilar Medicines Group, a sector of Medicines for Europe. Since I will be unable to attend the upcoming Biosimilar Medicines Conference this year, I welcomed the opportunity to speak with her about her thoughts and expectations for the upcoming event in London on April 26 and 27. One of the strengths of the Biosimilar Medicines Conference — now entering its 16th year — is that it serves as a forum for all stakeholders to discuss how biosimilar access can be broadened from nation to nation. As Lynch said, one of the biggest themes she expects will be discussed among all stakeholders at this year’s event are the biosimilar education, policy, and access inconsistencies that exist across different EU countries.
It was this knowledge that made me particularly excited to speak with Erin Federman, head of biologics, Europe, for Mylan, and chair of the Biosimilar Medicines Group Market Access Committee. Like Lynch, Federman will participate in one of the event’s panels entitled, “Caring For Patients With Cancer Today And Tomorrow: Seizing The Biosimilar Medicines Opportunity.” One thing that came across in our conversation, and which no doubt will be present during the panel as well, is Federman’s passion for the work she does, both for Mylan and with the Biosimilar Medicines Group. (I would like to mention that she graduated with a degree in English literature, which I was thrilled to discover given my background. I was once told English majors will rule the world.)
In her role for Mylan, Federman is responsible for setting and executing the commercial strategy for Mylan’s biologics across Europe. This involves working closely with a wide array of stakeholders, including country managers and other experts in policy, market access, supply chain, and medical affairs, to plan an actionable strategy to successfully launch and ensure access to each product. As such, Federman was also a great fit for chair of the market access committee for the Biosimilar Medicines Group. A self-proclaimed market-access geek, she emphasized her love of challenges — or, what she likes to call opportunities — in the biosimilar market, especially when it comes to understanding and pulling the different levers that exist across nations.
“We’ve had a lot of restrictive economic measures put in place in many European countries,” she explained. “We had the financial crisis. We have a growing and aging population. We have advances in science, which means conditions are identified sooner than they were in the past. These all contribute to increased pressures on the system.” She likened these pressures to a tea kettle built without a spout for the steam to escape. “Part of what we do is help put holes in the kettle to point the steam in the right direction,” she said.
At this year’s conference, which will delve into the ongoing work of “pointing the steam in the right direction,” Federman is looking forward to engaging with a number of stakeholders to ensure biosimilar policies are developed with varying stakeholders’ expertise and experiences in mind.
“We have experiences from large molecule gastroenterology and rheumatology biosimilars,” she said. “When you add in the various other smaller molecules, like human growth hormone, there’s a lot of biosimilar experience out there. We have to look at what is common amongst these different biosimilar experiences and learn what we can leverage and tailor specifically for the oncology market.”
Like Lynch, Federman said she’s particularly looking forward to engaging with the patient advocate representative on her panel. In order to best carry out her two roles with Mylan and the Biosimilar Medicines Group, it’s critical she hears what patients need, what knowledge gaps exist, and how those gaps can be addressed. Federman is particularly in touch with the emotional and human side of medicine. We can share with patients all the pharmacokinetics data in the world and emphasize that leading regulators have approved them. But at the end of the day, “People need to feel valued and that the treatment will work,” she said.
Safety Concerns Illuminate Need To “Reframe” Biosimilar Communications
Something that continues to surprise her is the amount of dialogue that persists about biosimilar safety. This isn’t to say safety isn’t a central goal of a biosimilar, but Federman chalks up these lingering questions to a general misunderstanding of the biosimilar regulatory process — and even of the regulators themselves. It’s no secret to any of us in this industry that approving a biosimilar requires a rigorous data package. And this data undergoes the same behind-the-scenes regulatory scrutiny as any drug. (Given the current scrutiny of biosimilars, one could argue it’s an even more stringent review than for originator drugs.)
“If there’s an opportunity on the panel, one of the things I would like to stress is the rigor and structure behind getting these products approved,” she offered. Though some of these concerns certainly could be because of a lack of education, lingering questions about safety (especially after education) raise questions about the public’s trust in the process or integrity of regulatory bodies. “This tells me we in the Biosimilar Medicines Group could not only better explain the regulatory process but also pull in some thought-leaders from that group to help put people at ease,” Federman said
A question I’ve posed before is whether this lingering question about biosimilar safety (after more than 10 years in Europe of proven safety) suggests a greater concern over the regulatory process and/or the integrity of the regulatory body. Now, this isn’t to say that regulators have not already been tirelessly and successfully working to improve and enhance understanding about the underlying science and regulatory process — especially in the EU. But when asked how she could see the conversation about the regulatory process evolving, Federman argued it would best be accomplished by reframing the conversation. Despite regulators’ diligent efforts to improve the underlying science and regulatory process, a lot of the communications surrounding regulators or the regulatory process is based heavily on scientific data. As such, Federman moved in favor of seeing more approachable discussions of the regulatory pathway. “There’s a particular range in which a biosimilar must fit in order to be considered approvable,” she said. “But this doesn’t tell those outside of the industry why there is a range and why it’s not one-for-one.”
We’ve both heard a number of examples in which making biosimilars have been compared to making wine or beer — and Federman’s go-to explanation is chicken noodle soup. (“I can give you my mother’s recipe, and you could make it and it will taste like her chicken noodle soup,” she described. “But it would be biosimilar chicken soup because it’s not her chicken noodle soup.”) Ultimately, by reframing these scientific concepts, Federman expects it would be easier to impart an important fact that has been quite understated to date — that all biologics vary from batch to batch. But even more importantly, she sees a need for humanizing the regulatory process.
For the patients’ sake, she expressed interest in seeing greater involvement of the regulator outside of the scientific review and approval process, as well as more EMA and EC stakeholder engagement. “It’s rare that I go to a conference and see a regulator speaking on topics that aren’t highly technical,” she pointed out. “Let’s meet the people. People are the ones approving these products, not a checklist.”
The Ongoing Search For Biosimilar Value
Our conversation also verged onto the topic of biosimilar value — a concept still taking shape as the market evolves. We often talk about the importance of biosimilars from a cost perspective. But a goal of the biosimilar industry is to extend the definition of a biosimilar’s value beyond the price tag. Though this topic is worthy of a longer article in the future (hint, hint), Federman emphasized the importance of building solidarity among all stakeholders to ensure people understand some of the immediate, tangible benefits of biosimilars, as well as some of the longer-term, more community-wide benefits. What these longer-term benefits will be still has yet to be fully uncovered. But at the upcoming Biosimilar Medicines Conference and in her role for the Biosimilar Medicines Group, Federman is excited to continue discussing how biosimilar policies — and the discussions about them — can remain informed by the human aspect.
“I’m living in Europe, and I’m also an American, so I understand the different healthcare systems,” said Federman. “At the end of the day, whether you’re paying Blue Cross Blue Shield, or I’m giving money to the health fund in Germany, that money is going for human beings, for our healthcare. So policy actually has a human impact.”
In fact, as she shared, thanks to the use of biosimilars, the EU5 has seen $1.5 billion in savings since Omnitrope arrived in 2006.
“That amount of savings could fund 40,000 nurses annually in the EU5 countries,” she pointed out. “Now, let’s think about what that could mean for patients.”
Hear more from Federman during the Biosimilar Medicines Conference on April 26 and 27 in London. If you can’t attend this year, I intend to follow-up with Federman and several other speakers about their biggest post-show takeaways and surprises. Stay tuned!