Article Summary:
The US Food and Drug Administration (FDA) has made a significant decision to eliminate the requirement for comparative clinical studies for most biosimilars. This move was praised by pharmaceutical industry representatives during a meeting on the reauthorization of the FDA’s Biosimilar User Fee Amendments (BsUFA) program.
Industry representatives highlighted the success of the BsUFA program in accelerating the development of biosimilars, which provide more affordable alternatives to biological drugs. They noted that the review process could be further enhanced through earlier communication about deficiencies that need to be addressed and emphasized the importance of maintaining stability and predictability at the FDA for the program’s continued success.
The upcoming negotiations between the FDA and the industry will focus on developing a commitment letter for the fourth iteration of BsUFA, which will cover fiscal years 2028-2032. The public meeting was held to gather feedback on the overall performance of the current BsUFA program and to identify elements that should be retained, modified, or eliminated to improve the program.
While the industry praised the FDA’s decision to eliminate comparative efficacy studies, they also noted room for improvement, such as addressing excessive review times and communication issues. Regulatory stability was also highlighted as a key concern, with the industry requesting the removal of the unique four-letter suffix requirement for biosimilar names.
Overall, the industry representatives expressed a commitment to working with the FDA to further strengthen the biosimilar review process and ensure that patients have timely access to affordable, safe, and effective medicines.