Member Spotlight | Q&A with Hillel Cohen
Hillel P. Cohen, Ph.D., Executive Director, Scientific Affairs, Sandoz, Inc., is a leading industry voice on biosimilars and biosimilar policy. With nearly two decades of experience working in biosimilars and “follow-on protein products,” Hillel has been instrumental in propelling the U.S. biosimilars industry forward. In particular, Hillel’s thought leadership on naming, interchangeability and broader biosimilars regulatory policy has helped position biosimilars as a solution for U.S. patients.
Hillel’s extensive experience spans the U.S. biosimilars market lifetime. In 2002, he was one of three individuals in a Novartis delegation to the Follow-on Protein Products (FOPPs) Key Issue Team, helping PhRMA develop an initial position on behalf of the U.S. originator industry for the precursor to biosimilars. For the next 12 years, he remained engaged on PhRMA and BIO scientific committees as a Novartis representative, helping shape biosimilars positioning. Now as the executive director of Scientific Affairs in the Sandoz division of Novartis, Hillel is focused on science policy related to biosimilar development.
Hillel has held numerous high-profile industry roles focused on creating a robust biosimilars market for patients, including as a member of the Biosimilars Council Education Committee. In 2015, Hillel led the efforts for the first-ever presentation of a biosimilar to a U.S. advisory committee, following Sandoz submitting a Biologics License Application for Zarxio (filgrastim-sndz). The Oncology Advisory Committee voted 14-0 to recommend approval of Zarxio for all indications. In 2016 Hillel was among the industry negotiators who met with FDA to assess and recommend updates when the Biosimilar User Fee Act was reauthorized by Congress (BsUFA2).
The Biosimilars Council is fortunate to have Hillel as a Sandoz representative to the Council Education Committee. His robust biosimilars background is crucial as we continue to advocate and educate on the promise of biosimilars for American patients.
“One of the challenges with current naming guidance is that it would not apply to currently approved originator biologics, in turn creating an inconsistent system that could result in confusion and create new pharmacovigilance challenges for current and forthcoming biologics.”
Read on for a Q&A with Hillel on critical topics currently facing the U.S. biosimilars industry.
Despite more than a decade of approval, the U.S. biosimilars market continues to face hurdles, limiting patient access and overall adoption. Some of these hurdles, such as the naming of biosimilar products have recently come to the forefront again following new FDA guidance. What is your main concern with the naming policy, and do you think it is hurting biosimilar uptake in the U.S.?
One of the challenges with current naming guidance is that it would not apply to currently approved originator biologics, creating an inconsistent system that could result in confusion as well as new pharmacovigilance challenges for current and forthcoming biologics. As a result, this will lead to new safety reporting challenges. It may also cause sponsors and other stakeholders to incur unnecessary system-related costs to monitor pharmacovigilance while limiting the commercial viability of biosimilar products.
The interchangeability designation is also a recent hot topic in biosimilars. While the FDA has recently released final guidance on interchangeability, where does the FDA stand on the naming of interchangeable biologics? Will this policy negatively affect uptake?
As described in the final guidance, interchangeable biologics will have suffixes attached to their non-proprietary names while their reference products will not. This creates a disparity in naming policies between interchangeable biologics and their reference products. This may inaccurately suggest to some that the products may be different in a meaningful manner and may actually create new pharmacovigilance challenges and limit patient access to biosimilars.
Besides clear guidance with a definitive focus on increasing biosimilars uptake, what else can be done to ensure market adoption of biosimilars?
In my opinion, obtaining approval for a biosimilar is only the first of many important steps:
- Biosimilars need to be accessible to the public – This means navigating potential patent litigation issues and obtaining positive contracting from payers.
- Patients and the healthcare community need to be comfortable using these new treatment options – This will require focused education in easy-to-understand language from trusted organizations.
- Industry needs to provide truthful and unbiased education – This includes explaining the new and unique development pathway for biosimilars, and how it is extremely rigorous in establishing product quality, safety and efficacy.
- The FDA and other key stakeholders need to combat misinformation – The biosimilars industry needs to help fight the claims that biosimilars may not be safe or effective.
“A successful biosimilars market will make biologics more affordable, which is critical given the financial strain that healthcare places on family budgets.”
Who do you see as the major champions for biosimilar uptake in the U.S.? What stakeholders are critical to ensured adoption?
The FDA has become a major champion for acceptance of biosimilars, with stringent requirements and regulations for the development and approval of these medicines to ensure their safety and efficacy profiles match their reference biologics. The FDA has a unique role because it has the trust of patients, prescribers and many others throughout the U.S. health care system.Patient advocacy groups have a major role as champions as well. In today’s information age, patients will research medications and treatment options on the internet. Patient advocacy organizations are highly trusted by newly diagnosed and chronic use patients.
How can non-industry biosimilars stakeholders take action to promote the development/understanding of biosimilars?
Non-industry stakeholders such as physicians, pharmacists and payers can work with patient groups to help them develop simple, accurate and easy to understand materials for patients. Dynamic materials like infographics, virtual whiteboards and other visually-compelling ways of conveying accurate information on biosimilar medicines can help provide important education on biosimilars. The FDA has already developed a wide variety of excellent educational materials. Sharing those is a simple way to promote the development and understanding of biosimilars.Additionally, professional societies should develop position statements and white paperswith abstracts or positions summaries that are accurate and can be quickly read. As trusted leaders, these groups can provide a validating position that advances biosimilars.
What excites you most about the future of the US biosimilars market?
Biosimilars can help provide millions of patients more affordable and accessible treatments. They create the potential to save the US healthcare system $54 billion over 10 years. A successful biosimilars market will make biologics more affordable, which is critical given the financial strain that healthcare places on family budgets. It will also enable more patients to be treated and possibly treated earlier, leading to improved patient outcomes.
I look forward to the day that biosimilars will be accepted in the U.S. to the same degree that small chemical generic drugs are widely accepted.
Hillel P. Cohen, Ph.D., is a leading voice in biosimilars and biosimilar policy. As executive director of Scientific Affairs in the Sandoz division of Novartis, Cohen is representative on the Council Education Committee, a founder of the U.S. Biosimilar Forum; has been an industry negotiator to the FDA; and has produced numerous presentations and peer reviewed journals including topics on biosimilar education, totality of evidence, switching reference products to biosimilars, interchangeability, manufacturing process changes and safety.
The views expressed here are those of Dr. Cohen as an individual and do not necessarily reflect the views of Sandoz Inc.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 22 percent of total drug spending. Additional information is available at www.accesiblemeds.org.