Analysis of Two FDA Guidances Impacting CGT

By: Michele Doughterty

The Food and Drug Administration’s (FDA) newly released Biosimilar Action Plan (BAP) aims to advance biosimilar development by focusing on four key areas:

• Efficiency in the development and approval of biosimilar and interchangeable products
• Scientific and regulatory clarity in the biosimilar development process
• Communication strategies to convey the benefits of biosimilars and interchangeable to the medical community and the public, and
• Ensure a competitive market landscape for biosimilar.

The goals outlined in the 2024 BAP aim to build on advancements gained through the implementation of the initial BAP published in 2018. The Agency will continue to evaluate approaches to streamline the clinical development programs for biosimilars, building on initiatives to evaluate the role of biomarkers in biosimilar development. FDA will continue to update guidance pertaining to biosimilar products, ensuring transparency and efficiency in the regulatory review, approval, and lifecycle management of biosimilar products.

Research priorities will focus on addressing knowledge gaps to advancing development of biosimilars and interchangeable products. One defined research priority aims to advance analytical technologies and predictive methods, in part to assist with the assessment of immunogenicity. FDA will continue communicating with healthcare providers and the public through various channels and modalities, with the goal of continually improving understanding of biosimilar and interchangeable products and their benefit for patients. Focusing on communication strategies to enhance general knowledge of biosimilar products promotes biosimilar uptake in the market and can help counteract misinformation on the benefits of biosimilar products to patients and consumers.

FDA’s commitment to the biosimilar pathway is evident in the goals of the BAP. Focusing on regulatory and scientific clarity for developers and clear, consistent communication to the healthcare community and the public will ensure that patients, caregivers, and providers will continue to benefit from the success of the biosimilar development pathway in the US.