Hillel Cohen, PhD, Education Committee co-chair for the Biosimilars Forum and executive director of Scientific Affairs for Sandoz, discussed whether disclosure statements are needed for biosimilar products and what they should contain, according to the biosimilar industry perspective.
The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on MJH Life Sciences®' Medical World News, The Center for Biosimilars® is pleased to welcome Hillel P. Cohen, PhD, executive director of Scientific Affairs for Sandoz. Can you introduce yourself and tell us a little bit about your work?
Cohen: I'm Hillel Cohen, executive director of scientific affairs at Sandoz Biopharma. I've been working in the area of biosimilars since 2003. I help explain the concepts of biosimilars to various stakeholders—with patient groups, health authorities, and within my own company. I also work with other companies, and I work with trade associations. For the Biosimilars Forum, I'm the co-chair of the education committee, and I'm also active in the education committee of the Biosimilars Council, a division of AAM [Association for Accessible Medicines].
So, I'm heavily involved with education topics. I've also discussed [biosimilars] and published in the areas of education, safety, interchangeability, naming, and other topics related to biosimilars.
CfB: Can you briefly describe the Biosimilars Forum for our audience?
Cohen: Sure, of course. The Biosimilars Forum is a nonprofit organization whose mission is to promote biosimilars-related education and policy advancement in the United States with the intent of expanding access and availability of biological medicines and improving health care. We are committed to ensuring the patients and prescribers have complete, truthful, and nonmisleading information about biosimilars.
CfB: What are the issues with biosimilar label descriptions as you see them? Is it not clear enough that biosimilars are as safe and effective as reference products?
Cohen: First, let me say we appreciate that the FDA is working on this study, and we look forward to working with the FDA as it evaluates its findings. We believe patients and health care providers need to be able to better understand the basic principles of biosimilars. In our comment letter, we urged the FDA to prioritize education about how biosimilars are as safe and effective as their originator products. Also, the FDA’s rigorous biosimilar approval process and high-quality standards should be emphasized.
We think patients should be aware that biosimilars have been available and a benefit to patients for many years. Currently, biosimilar labels identify the product as a biosimilar and they correctly rely on the data of the reference medicines' established efficacy and safety profile. The biosimilar development program is not designed to reestablish the already proven efficacy and safety.
CfB: Is the currently permitted label promotional material language too negative and why?
Cohen: The currently permitted promotional language for biosimilars does not contain mandatory disclosure statements because there are no safety or efficacy concerns about biosimilars that need to be disclosed. The efficacy and safety profile of the biosimilar matches that of the reference medicine. If the FDA decides to include disclosure language, it will be critical to explain things in a positive and easy to understand manner so as to avoid negative perceptions. The Forum has learned that even factual statements can be framed negatively.
CfB: Also, what effect is that having in the provider community in terms of uptake of biosimilars?
Cohen: At present, biosimilar use is relatively limited the United States for several reasons. One of which is the fact that they're not well understood by many health care professionals and patients. It's not the only reason but it is one of the major reasons.
In our opinion, the current practice of promotional materials not having disclosure statements is neutral. The addition of mandatory disclosure statements could be either positive or negative, depending on the tone and the content of the statement.
CfB: As part of its study, the FDA will examine perceptions with regard to similarity source and dosage administration of biosimilars. Can you explain why getting this wording right is essential to proper public perception?
Cohen: In regard to similarity, we want to make sure that patients and physicians know that biosimilars are as safe and effective as their reference medicine. We think it's important to make clear that the FDA has the same quality expectations for biosimilars as the ones that are applied to reference medicines and that the FDA review criteria are very high. The Forum believes that messages about source, dose, and administration should be avoided because they are unclear or are of minimal value.
The Forum believes that the source of biosimilars and the reference products are not facts that need to be disclosed in promotional materials. Both biosimilars and their reference medicines are manufactured by the use of biotechnology. The fact that a reference medicine was manufactured by use of biotechnology has never been of concern. So, it should be irrelevant for biosimilars.
And by definition, the dosage and administration must be identical for both the biosimilar and the reference product. So, as a result, this information has very limited value for patients who have not previously received the reference medicine. And patients who just switched to biosimilars from the reference medicines will not see a change in these parameters.
CfB: What are the shortcomings of this study as the Biosimilar Forum sees it?
Cohen: The FDA's request for comments shows that the agency is working hard to make sure the study is comprehensive. But first and foremost, it is not certain that disclosure statements are even necessary. The very fact that disclosure statements are added can add a negative message.
Moving forward, positive messages and positive tones should be used if there are to be disclosure statements. We have learned that even factual statements can be framed negatively, leading to a negative perception. It is very important that these negative perceptions and biases don't get introduced into the study. If used, disclosure statements should be relevant, avoid vague or overly complex topics, and avoid regulatory or health care professional jargon. Also, a sunset provision is needed after a set period of time, such as 3 years, to assess whether or not disclosure statements are still needed.
CfB: How can a study, like the FDA proposes, contribute to improvement of consumer and HCP [health care provider] perception of biosimilars and uptake?
Cohen: Now, it is not clear that disclosure statements are even needed. However, if disclosure statements are included, there's an opportunity to improve education about how biosimilars are as safe and effective as their reference medicines, that the FDA has a rigorous biosimilar approval process, that biosimilars are held to high quality standards, and that patients have been benefiting from use of biosimilars for many years.
CfB: What type of language would you specifically like to see incorporated into package label descriptions? And would this language satisfy the need for clinical objectivity and clarity?
Cohen: The Forum recommends 3 specific positive messages to be included in disclosure statements should the FDA decide that disclosure statements are needed. First, patients can expect that biosimilars will provide the same safety and effectiveness as the reference medicine. Second, the FDA has a rigorous review and approval process applying the same high-quality standards to both biosimilars and reference medicines. Third, patients have been benefiting from the use of biosimilars for many years.
CfB: And do you have any other thoughts on this FDA study?
Cohen: The Forum's comments on the FDA's notice are intended to help enhance the quality, utility, and clarity of the information collected in the FDA study by [providing information on] what topics were covered [in the study], the tone of disclosure statements, avoiding vague or overly complex messages, and establishing sunset provisions for disclosure statements. When biosimilar use is limited in health care systems, patients lose access to safe and effective lower-cost treatment options and the health care system loses billions in potential savings.
CfB: Can you describe the current playing field for biosimilars and your concerns about unfairness, language use, and anti-competitive practices in promotions?
Cohen: Forum companies and stakeholders have encountered disparagement and misinformation about biosimilars that have, at a minimum, caused confusion and likely contributed to slower uptake of some biosimilars.
CfB: What more could the FDA or FTC [Federal Trade Commission]do to give biosimilars the chance that they deserve to achieve greater uptake in this country?
Cohen: We were encouraged by the FDA and FTC's workshop and joint statement announcing that they were collaborating to dispel misinformation and address anti-competitive behavior. As stated in our recent BioDrugs publication, the public should be encouraged to report examples of potential biosimilar disparagement and misinformation to the FDA and FTC. These bodies will then evaluate the report and take actions as appropriate.
CfB: To learn more, visit our website at centerforbiosimilars.com, I'm Matthew Gavidia. Thanks for joining us.