FDA Proposes Reforms to Approval Process for Biosimilars

The FDA has recognized that one barrier to market entry of biosimilars is the high cost of development, which is often inflated by unnecessary comparative efficacy studies. In response, the FDA has proposed to eliminate unnecessary comparative efficacy studies and allow pharmaceutical companies to rely more heavily on improved analytical testing methods. The FDA has also recognized that the current biosimilar approval process is burdensome and has kept patients from accessing treatment and has therefore proposed to streamline the biosimilar drug development process to speed up approvals and encourage market entry. By optimizing biosimilar drug development and lowering research and development costs, the FDA hopes to encourage market competition and for patients to have expanded and less costly options.

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