JFDA Guideline for Registration of Biosimilars 2026

Published By : Jordan Food and Drug Administration | Consultation Type : Other |

Health

Closed

Published Consultation

4/13/2026
Comment End Date

5/13/2026
Consultation Definition

5/14/2026
Consultation Results

5/31/2026

Subject of consultation
Activities
Full legal text

Objectives

The Jordan Food and Drug Administration (JFDA) aims to support innovation and facilitate access to high-quality biosimilar medicines within the Kingdom, ensuring that patients benefit from safe, effective, and affordable treatment options. This guideline includes key updates aligned with reference health authorities regarding the requirements for developing these important medicines across all aspects. It reflects a modern and flexible regulatory framework that meets the evolving global standards in this field, supporting the quality, efficacy, and safety of these medicines while ensuring their timely availability to patients without delay.

Summary

The Jordan Food and Drug Administration (JFDA) has updated its biosimilars guideline to align with the latest global advancements and regulatory expectations, particularly those established by the European Medicines Agency (EMA) and its updated biosimilars guidelines, in addition to other reference health authorities such as US FDA and the WHO Biosimilars related guidelines. This revision reflects the evolving scientific understanding and regulatory landscape surrounding biosimilar development, emphasizing the importance of a tailored clinical development approach that is both scientifically justified and resource-efficient. Recent international experiences and scientific progress have demonstrated that comprehensive analytical characterization and comparative pharmacokinetic data can, under specific conditions, sufficiently establish bio-similarity without necessitating extensive clinical efficacy trials for every biosimilar candidate. The updated guideline incorporates these insights to streamline biosimilar development while maintaining rigorous standards for demonstrating similarity in quality, safety, and efficacy.