biosimilar substitution
Insider Insights

New Committee Paves the Way for Biosimilar Substitution in France


The increasing utilization of biosimilars in healthcare has prompted the French National Agency for Medicines and Health Products Safety (ANSM) to establish a new Temporary Scientific Committee (TSC). This committee is tasked with defining the conditions under which biologics can be substituted for biosimilars by pharmacists. The move comes as part of broader efforts to optimize the use of biosimilars, aligning with the objectives outlined in the Social Security Financing Act (LFSS) for 2024.

The creation of the TSC represents a significant step towards enhancing patient access to cost-effective alternatives while ensuring the safety and efficacy of biosimilar substitution. By the end of 2024, the committee aims to evaluate all currently reimbursed biologics and biosimilars, developing a comprehensive framework that includes clear conditions for substitution. This framework will provide guidance to healthcare professionals and pharmacists, facilitating the integration of biosimilars into treatment plans.

The LFSS for 2024 emphasizes the importance of optimizing biosimilar use as a means to generate substantial cost savings for the healthcare system. By promoting biosimilar substitution, the TSC contributes to broader efforts aimed at enhancing healthcare sustainability and efficiency.

Moreover, the establishment of clear guidelines for biosimilar substitution is expected to benefit companies invested in biosimilar development. As the prescription of biosimilars continues to grow, these companies may experience increased revenue streams. The TSC aims to lead this growth by providing comprehensive guidance and reducing barriers to prescribing biosimilars.

In summary, the creation of the Temporary Scientific Committee by the ANSM signifies a proactive approach towards promoting the safe and effective use of biosimilars in France. By defining clear conditions for substitution and aligning with broader healthcare objectives, the TSC aims to enhance patient access, improve healthcare sustainability, and foster growth in the biosimilars market.



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