From The Editor | January 16, 2019

Why This Biosimilar Initiative Is One To Watch In 2019

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By Anna Rose Welch, Editor, Biosimilar Development

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In July of 2018, a press release crossed my desk that caught my eye — The Biosimilars Forum announced something I had yet to hear (publicly announced, at least) within the biosimilar industry: a collaborative meeting among members of the Forum (biosimilar manufacturers) and 40 other stakeholder groups. Stakeholders attending this meeting included patients, physicians, pharmacists, government agencies, payers, and manufacturers. And according to the press release, this was one of several meetings this group had already held in 2018 that aimed to combine the voices and diverse intellects of the giant web of biosimilar stakeholders. So, when news came my way in early December that the Forum had established the Biosimilars Roundtable, which would be a working group comprising members of these 40 different stakeholder organizations, I was thrilled.

From the start of the biosimilar industry in the EU in 2006 and the U.S.’s subsequent and ongoing efforts to get it off the ground, education and multi-stakeholder dialogue have been stressed (and stressed again). At past conferences, I’ve heard stakeholders outside of the manufacturing community, such as patients, emphasize how helpful it was to attend industry and scientific conferences to become more familiar with the concept of biosimilarity and all the scientific, regulatory, and commercial work biosimilars entail. But after a conference concluded, I’ve often wondered how regularly interactions and dialogues have occurred between biosimilar makers and other stakeholders out in the real world. Because it’s rarely discussed in articles or news stories, it can appear, on the surface, as though the U.S., with its massive base of stakeholders, is still trying to get its ducks in a row when it comes to uniting for industry-furthering discussions outside of conferences.

But in the past year, there has been more publicity around the merging of the minds, if you will. Boehringer Ingelheim penned a great column last year about their ongoing coordination with patient advocacy groups, while last October, Celltrion announced a forum with patient advocacy groups on how best to introduce trastuzumab biosimilars into the breast cancer treatment paradigm. Another U.S. biosimilar trade group, the Association for Accessible Medicines’ Biosimilars Council, announced its collaboration with the American Pharmacists Association to educate this valuable stakeholder group. And now, we have the Biosimilars Roundtable, which has been a much-needed effort in the U.S. market, in particular.

Creating The Roundtable

As Julie Reed, president of The Biosimilars Forum, shared with me in an interview, the concept for this roundtable was inspired by the European Medicines Agency’s and the European Commission’s stakeholder workshop. Just as the U.S. today is working to build confidence and trust and combat misinformation about biosimilars, the EU went through a similar movement at the start of the biosimilar market. “Roughly 10 years ago, we reached out to the European Medicines Agency and said that, as developers of these products, we wanted to see biosimilars succeed; we want to see improved patient access and lower costs, but we were aware biosimilars were a brand-new market,” Reed explained. “That’s what ultimately led to the European Stakeholder workshop.”

Similar to the Forum’s experience with the EU regulatory bodies, Reed also credits the formation of the Roundtable in the U.S. to the industry’s strong relationship with the FDA. In fact, the FDA was responsible for connecting the forum to many of the stakeholders who went on to join the stakeholder workshop steering committee. In addition to members from Pfizer and Sandoz, this steering committee also comprises experts from a diverse array of stakeholder organizations, including the Arthritis Foundation, Lupus and Allied Diseases Association, Global Healthy Living Foundation, American Cancer Society Cancer Action Network, and American College of Rheumatology.   

“We started to bring these stakeholders together to get buy-in to the concept of a roundtable,” said Reed. “We all needed to start talking to each other. We started with a small group, and it just grew and grew.”

Membership to the Roundtable is currently invitation-only, and the organizations involved (outside of the steering committee) have not been announced in an effort to promote trust and open discussion. The end goal of the roundtable is to leave policy debates and agendas at the door and to focus on ensuring all the stakeholders in attendance have the information they need about biosimilars.

“Most of our discussions have been focused thus far on education,” Reed shared. “We’ve found it immensely helpful to unpack the different definitions and perceptions face-to-face and have conversations in which we’re all able to say things like, ‘We never thought of XYZ in this way — this is what we’re trying to say.’ We’re also hearing from those who represent patients about what’s important to patients, what kinds of education they need, and what they’re sensitive to. It’s been such a great help.”

Establishing New Educational Effort A Key Roundtable Priority In 2019

The discussions among the Forum and the 40 different stakeholder representatives have also led to what hopefully will be the start of a larger educational initiative from the Roundtable. In the same press release announcing the collaboration, the Forum shared news that the group had released its first biosimilars fact sheet. The concise, two-page document, which was written, edited, and approved by all 40 organizations in the Roundtable, covers several critical topics and definitions. Topics explored include the basics of biosimilars (what they are, how they’re made and regulated); definitions of common terminology, including biologics, biosimilars, reference products, and interchangeable products; what it means to transition to a biosimilar and for a biosimilar to be interchangeable; the reason biosimilars are coming to market; and common myths and misconceptions about biosimilars.

There were several aspects of this guide I found notable and particularly effective. For one, I think we can all agree that compiling as much information as the Roundtable did into two brief-pages is no mean feat. The integration of text boxes and graphics also break up the document visually, so on the surface it doesn’t appear to be an intimidating, text-heavy document.

Overall, it’s clear this educational document is meant, first and foremost, to emphasize the safety and quality of biosimilar products, seeing as the first two paragraphs and their subheads emphasize that these are FDA-approved products and are held to the same safety, efficacy, and quality standards as the originators. In fact, the two largest paragraphs in the document highlight why biosimilars and biologics are safe and effective. I’d argue this was a smart move, as opposed to spending several long paragraphs explaining some of the trickier commercial and regulatory ins-and-outs of biosimilars, such as transitioning and interchangeability. After all, lavishing great attention on these concepts could have unintentionally invoked caution about these two topics, and I think we can agree, there’s already enough of that kind of education out there.

I also greatly appreciated the Roundtable’s choice to use the term “transitioning” in this document, as opposed to switching. This decision harkened back to what I heard in the past from one Canadian patient organization, which argued the terms “switching” and “non-medical switching” typically have negative connotations. (In fact, as the group’s leader explained at a conference I attended last year, the advocacy group uses terms like “transition” as opposed to “switching,” and has taught other healthcare stakeholders to use that term.)

Though it remains to be seen how this document will grow legs, I’m happy to see attention being paid to regular, multi-stakeholder education and collaboration. The news came out in early December right before the holidays, and as we enter 2019, I think it’s important to keep this effort front-of-mind, as it highlights the types of collaboration we could stand to see more of on a regular basis in the U.S.

As Reed emphasized, “We in the Forum knew we needed to bring in all of these stakeholders because they’re the most important piece to building a sustainable market. This Roundtable will help us drive the support we need for biosimilars to succeed, while also maintaining and understanding the needs of the people we’re trying to serve.”