FDA’s Center for Drug Evaluation and Research’s Office of Therapeutic Biologics and Biosimilars (OTBB) released its first-ever curriculum toolkit for educators to help students in health care professional degree programs improve their understanding of biosimilar and interchangeable biosimilar biological products and their regulatory approval pathway in the U.S.

Sarah Yim, M.D., OTBB director, explains the new educational toolkit and its importance to medicine, nursing, and pharmacy students as well as educators.

Sarah, before we delve into the specifics of this new toolkit, why is OTBB creating the tool kit? Why now?

Biological products - also called biologics - are a fast-growing market that comprise a broad range of treatment options for patients. Biosimilars and interchangeable biosimilars are biologics that can improve access to care for patients by increasing the number of medication options on the market and potentially lowering costs. FDA has approved biosimilars to treat diseases such as cancer, rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and diabetes. Just this year, the agency approved the first two interchangeable biosimilar products, which meet additional requirements and may be substituted for the reference product without a prescriber’s involvement, similar to how generic drugs can be substituted, subject to state pharmacy laws. With the increased availability of biosimilars, this toolkit is timely to help train those who will be working in the field and will help future health care professionals educate their patients and facilitate shared decision making.

This toolkit is designed for educators to help students in health care professional degree programs for medicine, nursing, physician assistants, and pharmacy improve their understanding about biologics, including biosimilars. As these students transition into professional practice, they can play a key role in educating patients about biosimilar and interchangeable biosimilar products and can discuss with patients if a biosimilar is a treatment option in a particular clinical case.

The objectives of our biosimilar educational toolkit are to provide definitions related to biological products, including reference products (also called originator biologics), biosimilar products, and interchangeable biosimilar products. The toolkit explains the different regulatory approval pathways for reference and biosimilar products, including the required data and information needed to support biosimilar and interchangeable biosimilar approvals. The toolkit also includes considerations for prescribing and dispensing biosimilar and interchangeable biosimilars.

Seems like a lot of important and needed information. Who is the toolkit for and how can it be used?

Yes, you’re right. The toolkit is a great aid for educators to help students before they become health care professionals, as it is a comprehensive overview of biosimilar and interchangeable biosimilar products.

Because these educators and students are our target audience, we are disseminating the toolkit to clinical societies and academic associations, as well as medical, nursing, and pharmacy schools.

The toolkit is designed to assist teaching faculty who would like to incorporate topics related to biosimilar and interchangeable biosimilar products into students’ education and training. The materials are modular in nature, allowing teaching faculty to integrate the topics about biosimilars into class lectures, online learning platforms, class discussions, and at-home assignments, as appropriate. The materials consist of a teaching guide, information sheets (seven), slide decks (two) with assessment questions, four videos, discussion questions (two documents) and three case studies.

The materials in this toolkit focus on two different groups or levels of health care degree students and their expected learning needs:

Materials at level 1 provide a high-level overview of foundational biosimilar topics and describe how biosimilar products fit into the broader category of therapeutic biological products. The materials also describe the availability of biosimilar and interchangeable products in the U.S. health care market, the role providers play in prescribing, and information on interchangeability. Students at level 1 may be beginning their medical training or have a limited exposure to biological products and need a basic understanding of the concepts.

Materials at level 2 provide an in-depth look at scientific and regulatory topics related to biosimilars and their practical applications. Materials at this level describe the commonalities between biosimilars and reference biological products, discuss different approval pathways for biological products, examine variation inherent in all biological products, and provide information related to prescribing biosimilars. Students at level 2 may be those nearing the completion of their training and preparing to enter clinical practice where they may encounter patients being prescribed biological products as part of their treatment plans.

The materials in the toolkit are designed to meet a variety of teaching needs. The materials complement each other so faculty and instructors can select the resources that best fit the knowledge needs and learning styles of their students. The presentation decks serve as the core for the other educational materials, whether for use in a class lecture (e.g., the deck and explanatory videos) or assigned to students in a classroom discussion forum (e.g., information sheet, case study, discussion questions).

Why is this toolkit so significant?

This is the first FDA-developed biosimilar curriculum toolkit. The toolkit offers basic, foundational concepts as well as more in-depth regulatory and scientific concepts.

Congress, through the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through increased competition.

Education efforts are a goal in the Biosimilars Action PlanExternal Link Disclaimer and recent executive and legislative actions- The Executive Order on Promoting Competition and the Advancing Education in Biosimilars Act of 2021. The Act directs the Secretary of Health and Human Services to advance education and awareness among health care professionals regarding biological products, including biosimilar products. The Act also supports providing educational materials to health care professionals through FDA’s website on topics that are included in the toolkit, such as key statutory and regulatory terminology, the relationships among reference products, biosimilar products, and interchangeable biosimilar products, and information related to FDA’s approval standards, among other things.

This toolkit provides teaching faculty with a variety of educational resources designed to provide flexibility in the manner and amount of information related to biosimilar and interchangeable products that can be incorporated to suit the needs of the individual faculty and program. We hope this will increase the utility of these resources and lead to increased knowledge and real-world application of the concepts among students in relevant health care professional degree programs. More than anything, we hope this toolkit will help the health care professionals of tomorrow become more familiar and comfortable with biosimilars and that more patients will have the opportunity to access these safe and effective treatment options as a result.