The Biosimilars Forum: Biosimilar Education Relies On "Pure Science"
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
Education is a leading initiative for those looking to bolster the biosimilar industry, both in the U.S. and abroad. Companies and biosimilar industry organizations have been exploring a number of strategies to ensure doctors, payers, and patients understand what biosimilars are and the benefits they can provide. One of these efforts is being spearheaded by the Biosimilars Forum. In February, the industry organization announced the release of its educational initiative known as the “Partnership for Biosimilar Education and Access.” The Forum comprises a mix of high-profile brand companies and generics manufacturers, as well as several pure-play biosimilar companies. At times, these companies might have different opinions on biosimilar policy. But when it comes to education, the Forum members are very much aligned.
At the beginning of February, the organization posted two educational documents to its webpage: one entitled Biosimilars Overview and the other responding to Biosimilar FAQs. As Sandoz’s Hillel Cohen, the co-chair of the education committee, emphasizes, at the heart of these documents is a strong consensus among member companies on the science of biosimilars. “When you focus simply on the pure science of biosimilars, there’s a close alignment of opinion among all member companies,” Cohen offers. The realization of this unity helped the Forum determine the steps it needed to take to create these educational documents.
Establishing The Educational Initiative: First Steps
Before the Biosimilars Forum even got its name, a list of topics was circulated among a group of companies. These companies were then to select the highest priority topics. According to Cohen, every company identified education as one of the top three most important topics for the biosimilar industry. Once the group decided it would be in its best interest to establish an education committee within its ranks, it sought meetings with the FDA to ensure the scientific information being purveyed would be consistent with the regulatory agency. “The FDA didn’t tell us how or what to discuss in our education effort, nor did the agency endorse them. We just wanted to make sure our approach and views were consistent with theirs,” Cohen explains.
Following the selection of topics, the Forum’s documents went through several iterations and were distributed among the members’ scientists, communications, and legal people for revisions. The end result, Cohen says, is a “unanimous, science-based position of the Forum’s member companies.” The Forum can show patients and physicians these documents and say, “Here’s a set of science-based documents that we and other companies with whom we’re competing in the biosimilar space all agreed upon. To be able to tell them every member agrees on the science underpinning biosimilars is very powerful.”
What Physicians Need To Know About Biosimilars: The Basics
The Forum identified three groups that primarily need this education: Healthcare professionals, patients/patient advocacy groups, and the payer community. In particular, the members decided that targeting healthcare professionals would be the best place to start, especially since patients will likely go to their physicians to learn more about biosimilars.
As Cohen stresses, the Forum set out to create a stepwise approach to education. While there are physicians that have some understanding of biosimilars today, there are an equal number or, likely, more, who are unfamiliar with biosimilars. In fact, there is a general lack of understanding over the nuances of biological drugs, not just biosimilars. For many physicians, a cancer drug is simply perceived as a cancer drug, and an arthritis drug is an arthritis drug. The current list of treatments in these indications includes both small molecule and biologic drugs. Therefore, the Forum members felt it was important to start by defining what a biologic is. This established the starting point for the group’s subsequent discussion of biosimilars.
As Cohen describes, the key points physicians need to understand about biosimilars is that “they are not perfect copies. With all biologic drugs, including biosimilars, there is always some variability from lot to lot over time.” But thanks to advances in analytical capabilities, both biologics and biosimilar makers can now have a detailed understanding of the structure of the molecule and of each lot. In turn, the FDA can make the determination upon review of a BLA that the biosimilar does not contain any clinically meaningful differences from the reference drug. As Hillel says, “Ensuring physicians understand that an FDA approval stems from finding no clinically meaningful differences between the biosimilar and originator is key to physician comfort and uptake.”
Understanding How Biosimilar Data Differs
One of the biggest concerns for the Forum, and indeed for other organizations and biosimilar makers, is that biosimilars may have slow uptake because of perceptions about quality and safety concerns. Like all stakeholders, the Forum aims to emphasize that biosimilar products should not evoke fear. Cohen says, “Because biosimilars are more complex than chemical generics, physicians and patients have to be comfortable with the science behind them.”
But what’s especially important for doctors to become familiar with is the type of data affirming the safety and efficacy of a biosimilar compared to an originator biologic. For an originator biologic, the pivotal studies determining safety and efficacy are key to building confidence in the molecule. But “the root of biosimilar development is based on the science of knowing how to make it and prove that you’ve made it properly using the appropriate manufacturing and analytical technology,” Cohen describes.
The basis of a biosimilar is comparative analytics of the biosimilar and reference drug. Determining what happens to the drug in the body and how the body responds to the biosimilar and reference product — the pharmacokinetic and pharmacodynamic studies — are very important in the development of biosimilars. The final safety and efficacy studies, the Phase 3 studies, are held to confirm what has been determined through the other phases of development — that these products are highly similar to that of the reference product and that there are no clinically meaningful differences between the two. As such, “We have to educate healthcare professionals that the entire paradigm of evidence they’ve been taught to accept for a new drug is different for a biosimilar,” Cohen states. “A biosimilar requires a different type of proof as compared to a novel biologic.”
How Is The Initiative Performing Today?
The Forum is currently rolling these educational documents out to healthcare professionals in a number of different ways. For one, the group has been attending and plans to have booths at future national conferences of doctor associations. In 2016 so far, the Forum has attended or plans to attend upwards of six meetings, including the American Academy of Dermatology, Digestive Disease Week, American Society for Clinical Oncology, and the American College of Rheumatology. Similarly, to best reach a large number of physicians, the group is seeking meetings with the staff of large professional societies in the hopes that this education will trickle down to each society’s members. In fact, one of the most important things the Forum has learned since its launch a year and a half ago is that the different specialty areas have different needs in terms of education. As such, tailoring education outreach to these different professional societies and physicians groups is a key goal for the Forum moving forward.
Social media, in particular Twitter, has been an important way to share these educational messages. For instance, the Forum is well on its way to accruing 3,300 followers on Twitter (@USBiosimilars). Similarly, each member of the Forum, and any future members, are free to use the documents for their own education purposes. In the first three months since launch, the education materials have been downloaded 660 times, and the educational pages on the Forum’s website have had roughly 1,000 views. “Over time, we hope to continue making an impact on the knowledge about biosimilars,” says Cohen, because ultimately, we want healthcare professionals to be knowledgeable about biosimilars and willing to prescribe them if they feel they are appropriate for their patients.”
Future Educational Efforts
In addition to the educational documents, the Forum also invested its efforts on putting together a survey of healthcare professionals. The goal was to get a sense of professionals’ knowledge of biosimilars and what misconceptions might exist. “We will repeat the survey in two or three years to see whether the industry’s educational efforts as a whole have led to a greater understanding,” Cohen explains.
Like the educational documents, this survey was not carried out to reinforce policy positions. Instead, the survey questions were presented neutrally, so as not to bias responses. The results of this survey, which was completed in January, have yet to be released or distributed publically. The Forum is first looking to have the survey results published as a peer-reviewed journal article. As Cohen explains, “It’s really a starting point. We needed to know what the baseline of knowledge is. That, to a degree, will help guide the type of efforts we need to move forward with future education efforts. We’ll repeat the survey in the future to see if there is an increase in knowledge as a result of education and physician experience with biosimilars,” says Cohen.