The Importance of Naming for Market Adoption of Biosimilars
Executive Director, Scientific Affairs, Sandoz, Inc.
Written by Hillel P. Cohen
Biosimilars are a competitive, effective alternative for U.S. patients prescribed brand biologic treatments, however despite over ten years of approvals, the U.S. has not yet realized the full potential of biosimilars. While we continue to see additional approvals, it has become clear that obtaining approval for a biosimilar is only the first of many important steps to ensure market adoption.In order to advance biosimilars in the U.S., we must tackle a critical challenge: patients and the healthcare community need to be comfortable using these new treatment options. This will require focused education in easy-to-understand language on priority topics from trusted organizations such as patient groups, industry associations and government entities.
Biosimilars can help provide millions of patients more affordable and accessible treatments. They create the potential to save the U.S. healthcare system $54 billion over 10 years. A successful biosimilars market will make biologics more affordable and enable more patients to be treated and treated earlier, leading to improved patient outcomes. However, we must streamline regulations on critical areas such as naming and interchangeability to allow the biosimilars market to flourish.
Naming of Biosimilars & Interchangeable Biologics
Clarity on the naming of biosimilars and brand biologics is critical to demonstrating the safety and efficacy of biosimilars when compared with a reference biologic. Easy-to-understand language is just one of the reasons the new FDA naming guidance is misleading and can hinder adoption of biosimilars and interchangeable products. It is important that we develop policies that encourage adoption of safe, effective biosimilars and clarity on critical topics such as naming and interchangeability are essential to ensuring market development.
In the recent update of the naming guidance, the FDA has decided that the interchangeable biologics will have suffixes in the same manner as that assigned to biosimilars, and that the suffixes would not change if a product is first approved as a biosimilar and then approved later as an interchangeable biologic. Furthermore, the reference products currently approved for interchangeability will not have suffixes. Since this guidance would not apply to currently approved originator biologics, it would create an inconsistent system that could result in confusion and create new pharmacovigilance challenges for current and forthcoming biologics.
This will lead to new safety reporting challenges. It may cause sponsors and other stakeholders to incur unnecessary additional pharmacovigilance burden and cost while limiting the commercial viability of biosimilar products. As proposed, the FDA’s draft guidance to track cases using a unique suffix added to the natural product number (NPN) of some products will create 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.
As a participant and leader in the development of biosimilar policy in the U.S. for more than 15 years, I have seen some parties advocate for assigning unique names to biosimilars primarily to differentiate them from their reference products. FDA-approved biosimilars have safety and efficacy profiles that match their reference biologics, and any attempt to suggest otherwise can impede patient access to potentially lifesaving biologics and result in increased spending for healthcare systems.
It is certainly possible to prescribe and properly track biosimilars by means other than creating unique names by the addition of suffixes, as is currently proposed in FDA draft guidance.
Industry Role in Biosimilars Uptake
In the fight for wider acceptance of biosimilars, the biosimilar industry has to help the FDA and other key stakeholders accurately share the promise of biosimilars and combat misinformation and suggestions that biosimilars may not be safe or effective. It is gratifying to see that 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 they have the trust of patients, prescribers and many others throughout the U.S. healthcare system.
There are multiple tools already in place to track the safety of biosimilars in the U.S. If the existing tools are not being used properly or sufficiently, I feel the solution is to improve the use of existing well-designed systems, and not to make the system more complicated. This has been done in Europe for over ten years and the Canadians and Australians are adopting the same practices.
Biosimilars are relatively new in the U.S. and today’s physicians, nurses and pharmacists did not learn about them during their education. Those who know about biosimilars and the promise they hold share the responsibility to educate and raise awareness, particularly among trusted medical professionals. The FDA has developed a wide variety of educational materials for healthcare professionals and is working to create educational materials for patients. In the future, knowledge about biosimilars should be incorporated into the curricula of pharmacy schools, nursing schools and medical schools.
Stakeholder Education Is Essential
Industry plays a central role in providing truthful and unbiased education. Industry experts should explain the new and unique development pathway for biosimilars, and how it is extremely rigorous in establishing product quality, safety and efficacy. These experts also need to communicate key results from the post-approval observational studies that generate real-world evidence and can provide additional reassurance of effectiveness and safety.
Patient advocacy groups play a major role as well. In today’s information age, patients will research medications and treatment options on the internet, and these advocacy organizations should produce reliable educational materials. Patient advocacy organizations are highly trusted by newly diagnosed and chronic use patients. It is important that healthcare providers understand that FDA-approved biosimilars have the same route of administration, dosage form and strength as their reference biologics and demonstrate matching purity, potency, safety, efficacy and immunogenicity
I look forward to the day that biosimilars will be accepted in the U.S. to the same degree as small chemical generic drugs are widely accepted.
About the Author
Hillel P. Cohen, 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 forward the U.S. biosimilars industry. 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.