BioRationality: Developer-Led Biosimilar Education Unnecessary, FDA’s Got It Covered

Teaching health care professionals and other stakeholders about biosimilars and how they are developed and approved is common among many associations and groups. This practice should end now, as the FDA releases a comprehensive Teaching Resource Guide as a toolkit to educate health care professionals about biologics, mainly focusing on biosimilars and interchangeable biosimilars. The guide serves as a resource for teaching faculty to help students in healthcare programs—such as medicine, nursing, physician assistants, and pharmacy—gain a deeper understanding of biosimilars, their regulatory approval pathways, and their role in patient care. However, this should also serve the need to educate all stakeholders. The following highlights how the FDA explains biosimilars are of pivotal importance.

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Introduction to Biosimilars¹

As the use of biosimilars expands, health care professionals are expected to play a critical role in guiding patients through shared decision-making regarding biosimilar use. The FDA's goal in developing this guide is to ensure that future health care providers are equipped with the knowledge needed to educate patients about these products' safety, efficacy, and benefits.

Goal and Objectives of the Toolkit

The toolkit provides teaching faculty resources to incorporate into curricula to educate students about biosimilars. Specifically, the toolkit helps students understand the definitions, regulatory approval pathways, and practical considerations in prescribing and dispensing biosimilars. The toolkit is intended to meet the learning needs of students at different stages of their training by providing both basic and advanced materials.

The 4 key objectives of the toolkit are:

1. Define biologics, reference products, biosimilars, and interchangeable biosimilars.
2. Explain the regulatory approval pathways for biosimilars and interchangeable biosimilars.
3. Outline the data and studies required to demonstrate biosimilarity and interchangeability.
4. Discuss the practical considerations in prescribing and dispensing biosimilars and interchangeable biosimilars.

Two Levels of Learning

The toolkit is structured into 2 levels, catering to students at different stages of their training:²

• Level 1: Foundational Concepts
  • This level provides a high-level overview of biologics and biosimilars and explains the regulatory framework surrounding their approval. Topics include the definition of biosimilars, the differences between biosimilars and generics, and the availability of biosimilars in the US market.
  • Students at this level are likely new to the topic and require a basic understanding of the relationship between reference products and biosimilars and their clinical application.
• Level 2: Advanced Regulatory and Scientific Concepts
  • This level delves into more complex topics, such as the inherent variation in biologics, the comparative analytical assessments used in the approval process, and the totality of the evidence approach used by the FDA.
  • Students at this level are expected to understand biosimilarity scientifically, particularly the relationship between clinical and analytical data in establishing biosimilarity. Advanced topics like post-translational modifications, critical quality attributes, and the Purple Book (which lists licensed biological products) are also explored.

Types of Resources

The toolkit provides a variety of resources to support teaching and learning, including:

• Presentation Decks:
  • These slide decks are designed to introduce fundamental concepts about biosimilars and are equipped with animated videos, visuals, and knowledge-check questions. The slides also include key takeaways summarizing the most critical points and links to additional resources.
• Case Studies:
  • Narrative-driven case studies are used to simulate real-world scenarios. These case studies allow students to explore practical applications of biosimilars in clinical settings, examining the decision-making process of health care professionals who prescribe or dispense these products.
• Information Sheets:
  • Concise information sheets provide a deeper look at specific topics, such as the regulatory approval process, the variation in biologics, and the critical considerations for prescribing biosimilars.
• Explanatory Videos:
  • Short videos visually explain both foundational and advanced topics. These videos range from 2 to 6 minutes and offer a quick and engaging way to introduce or review material.
• Discussion Questions:
  • The guide includes knowledge assessment questions that help students reflect on and discuss the material. The questions are available in multiple-choice formats and can be used to assess both basic and in depth understanding.
• Exercises:
  • Real-world examples are provided through exercises, guiding students through scenarios like navigating the Purple Book or comparing biosimilar product labels to reference products.

Case Studies for Practical Understanding

The case studies included in the guide offer a practical way to apply theoretical knowledge. For example:

• “What is a Biosimilar?” Introduces a primary care nurse to biosimilars and highlights the differences between generics and biosimilars.
• “Biosimilar and Interchangeable Biosimilar Insulin Products” follows a physician in training who learns about the availability of biosimilar insulin products in a community health setting.
• “Interchangeable Biosimilars” explores the decision-making process of a pharmacist considering switching a patient to a biosimilar due to insurance constraints.

Knowledge Assessment and Key Takeaways

Each module in the toolkit concludes with key takeaways that summarize the most important concepts. Knowledge assessment questions at both levels help students evaluate their understanding of biosimilar topics. These questions encourage deeper thinking, particularly regarding comparing biosimilars and their reference products, the importance of clinical and analytical studies, and the practicalities of prescribing biosimilars.

Additional FDA Resources

The toolkit links to FDA resources, such as the Purple Book and Drugs@FDA, where health care providers can find information on biologics and biosimilars. These resources offer information for educators and students, helping them stay informed on the latest biosimilar regulations and use developments.

Conclusion

The FDA's Teaching Resource Guide is a comprehensive toolkit to prepare future health care providers to understand and effectively use interchangeable biosimilars in clinical practice. By providing both foundational and advanced resources, the guide ensures that students at all levels of training gain a thorough understanding of the regulatory pathways, scientific concepts, and practical applications of biosimilars.

This resource is critical for helping health care professionals engage in informed decision-making and patient education regarding biosimilars, which are increasingly important in modern health care. Through a combination of presentations, case studies, videos, and exercises, the toolkit equips teaching faculty with the necessary tools to educate the next generation of health care providers.

References

1. Biosimilars. FDA. Updated March 1, 2023. Accessed October 21, 2024. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars

2. Curriculum Materials for Health Care Degree Programs | Biosimilars. FDA. Updated October 16, 2024. Accessed October 21, 2024. https://www.fda.gov/drugs/biosimilars/curriculum-materials-health-care-degree-programs-biosimilars?utm_medium=email&utm_source=govdelivery