Advancing biosimilar approval and adoption: The FDA's initiatives and impact

The landscape of biosimilars has rapidly evolved over the past decade, with the US Food and Drug Administration (FDA) spearheading efforts to enhance their approval and utilization. Notable examples of these efforts include changes to labeling, examining the safety outcomes of switching, being flexible with the required clinical evidence for approvals, and educating stakeholders.

The current state of biosimilars

The last 8 years have seen over 40 biosimilars approved by the FDA, significantly increasing access to healthcare.1 These products are being used across various therapy areas, including immunology, oncology, supportive care, ophthalmology, and diabetes mellitus. This year, notable approvals include:2