By Lara Crissey, Boehringer Ingelheim Pharmaceuticals, Inc.
2017 was an important year for biosimilars in the U.S., with new FDA approvals and highly anticipated draft guidance on regulatory policies like naming and interchangeability. These milestones show a growing U.S. market for biosimilars and indicate that these medicines are seen by industry, regulatory bodies, patient groups, and healthcare providers as a potential source of much-needed value that will help drive a sustainable healthcare system in the future.
While these advancements are an important first step, the U.S. biosimilars market is still in its early stages, with a long road ahead. Only three of the nine biosimilars approved by the U.S. FDA are available to patients, compared with more than 30 biosimilars on pharmacy shelves across Europe.
Biosimilars are a complex topic not easily understood by the general public, or even healthcare providers. As Anna Rose Welch, executive editor of Biosimilar Development, points out in a recent article, “as soon as you have to explain that there are small and large molecule treatments to get at the heart of why biosimilars cannot actually be identical to their reference products, people’s eyes glaze over.”
As a result, establishing public trust that biosimilars are an effective, safe, and more affordable alternative to a branded reference product presents a challenge to all companies developing these new treatment options. At Boehringer Ingelheim, our clear first step is ensuring healthcare providers understand the comprehensive data packages we develop, with robust analytics and clinical data required by the FDA, to demonstrate our biosimilar candidates are highly similar to their reference products in efficacy, quality, safety, and purity. In addition, standard practice across therapeutic areas, including for our biosimilar candidates, is to present data at key medical meetings and submit manuscripts to important medical journals. In some instances, we may also provide clinical evidence that goes beyond the requirements of the FDA, in an effort to provide additional data that can be more relevant to healthcare providers in their everyday practices.
But when it comes to biosimilars, building confidence that these innovative medicines can deliver the same experience as a branded medicine will ultimately require more than communicating successful clinical trial results. Until we reach the point when biosimilars have been available to patients in the U.S. for several years, the public will likely continue to misunderstand their benefits in the real world and gravitate toward the more familiar brand names. Therefore, it is critical that we offer educational resources that demonstrate to healthcare providers the therapeutic and cost-saving potential of biosimilars — and that we make sure these tools can be easily adapted for patients and their families, who want to be informed and proactive in their healthcare experience.
The importance of education for the successful uptake of biosimilars is a sentiment shared by FDA Commissioner Scott Gottlieb, M.D. In a recent speech at the America’s Health Insurance Plans’ National Health Policy Conference, Gottlieb stated that in addition to establishing a clear regulatory pathway for biosimilars, “the FDA is also committed to educating clinicians and patients about the safety and effectiveness of FDA approved biosimilars through various formats — including videos, webinars, and conferences.” While the FDA’s comments are encouraging, developing and distributing these resources in a way that truly meets the unique needs of each stakeholder is an impossible task for either the FDA or a biosimilars developer to achieve alone.
Instead, one of the best ways to drive meaningful change is by collaborating closely with the patient groups that are already working to foster a better understanding of the potential of biosimilars. In the spirit of this collaboration, the following are some of the insights that a few organizations have shared around how we can work together to increase understanding of biosimilars.
Start with identifying the gaps.
Biosimilar use in the U.S. is often compared to the current role of generic medicines. But while biosimilars, like generics, provide competition to established brand products that may result in increased patient access and cost containment, they differ from generics in many other ways. Not only are biologics much more complex than chemically synthesized drugs, but generics have also been around for over three decades, allowing healthcare providers to draw on many years of real-world evidence. Understanding knowledge gaps like these is key to fostering a better understanding of biosimilars.
“The Foundation views biosimilar education as ongoing — we started with focus groups to understand the learning gaps and then built multi-format resources to engage the different learning styles. The programs we launched in 2016 focused on topics such as defining biosimilars as being separate and different from generics, explaining concepts like extrapolation and interchangeability, sharing safety data from Europe, and encouraging proactive discussion on biosimilar options between patients and providers and vice versa.” – Laura Wingate, senior vice president of education, support, and advocacy, Crohn’s & Colitis Foundation
Looking ahead, the Crohn’s & Colitis Foundation intends to expand its educational resources to focus on the potential cost-savings of biosimilars and ensure patients and providers have the tools to proactively discuss biosimilars as part of the treatment decision-making process.
The role that manufacturers will play in the development of these resources is in readily providing information and data that these groups can source, along with content from biosimilar coalitions, the FDA, and academic studies.
Currently, Boehringer Ingelheim is also working closely with the Colorectal Cancer Alliance (CCA) to help further this free-flowing exchange of educational resources and information.
“A collaborative, educational partnership with Boehringer Ingelheim has afforded the Alliance and their community of patients, families and caregivers, the advanced opportunity to educate around the importance of biosimilars. We encourage everyone to advocate on behalf of their own health, and through partnerships like this, we are able to provide the required thought leadership to do so.” – Sara Geis, director of marketing & communications, Colorectal Cancer Alliance
Provide varying perspectives.
What makes biosimilars so promising is that they provide additional safe and effective treatment options; they also have the potential to impact the sustainability of the healthcare system overall. Biosimilars have had a notable impact on affordability and patient access into the European market, and the hope is that the same result will be seen once biosimilars are adopted in the U.S.
Sharing educational resources that explain biosimilars from the perspective of not only healthcare providers and patients, but also from the FDA, manufacturers, and payers will be important when communicating the larger potential of these medicines.
“As the leading voice for individuals living with psoriasis and psoriatic arthritis, we have been talking about biosimilars for years, as we know the psoriatic disease community is keenly interested in research and the development of new treatments. We’ve issued position statements on biosimilar arrival to the U.S. market, the biosimilar approval pathway and the relationship between patients and providers. We’ve also shared infographics from the FDA for the benefit of patients. Since these topics can be complex, we find that it is easiest to share information as part of a broader conversation and broken into digestible segments so it is easier for interested stakeholders to engage. Collaborating with the FDA, clinicians, payers and industry partners through educational programming and advocacy efforts allows us the opportunity to not only offer the patient perspective, but also that of the various stakeholders interested in developing this group of therapies.” – Leah Howard, J.D., chief operating officer, National Psoriasis Foundation
It will be important for developers to work closely with their advocacy partners to create a “library” of information that can help build a 360-degree united front in fostering a better understanding of biosimilars.
These are just some of the ways we can work better, together. Boehringer Ingelheim is a founding member of the Biosimilars Forum, a nonprofit group working to advance biosimilars in the U.S., with the intent of expanding access and availability of biological medicines and improving healthcare. We are also a founding participant of the Biologics and Biosimilars Collective Intelligence Consortium, a multi
-stakeholder organization dedicated to monitoring biosimilars and their innovator products, using anonymous data from more than 100 million patients to track the efficacy and cost-effectiveness of biosimilars through post-market observational studies.
Our mission is to improve the lives of patients by delivering solutions for all stakeholders, and we are confident that biosimilars can further this vision. Realizing this goal will require continued partnering with patient advocacy groups to improve the public understanding of and trust in biosimilars, so that we can create a meaningful and long-lasting difference in the lives of patients and their families.
About The Author:
Lara Crissey is the director of patient advocacy and professional relations for Specialty Care at Boehringer Ingelheim Pharmaceuticals, Inc.