Disposition ANMAT – N° 1741/2025
Healthcare & Life Sciences Department Report | DispositionANMAT – N° 1741/2025
On March 17, 2025, Disposition 1741/2025 (the “Disposition”) was published in the Official Gazette, through which the National Administration of Drugs, Food, and Medical Technology (“ANMAT”) establishes the “Requirements, Guidelines, and Criteria for the Comparability Exercise of Biosimilar Medicinal Products”, within the framework of ANMAT Disposition No. 7729/2011.
Disposition 7729/2011 approved the requirements and guidelines for the registration of biological medicinal products whose qualitative-quantitative composition, therapeutic indication, and proposed route of administration have precedents in other biological medicinal products previously authorized and registered by ANMAT.
According to the Disposition’s recitals, it is deemed necessary to further develop the regulatory framework for the approval of new biosimilar products, with a focus on regulations that detail the requirements for demonstrating bio similarity. These updates align with internationally recognized high-surveillance health standards, ensuring greater specificity regarding how comparability studies should be conducted.
In this regard, considering the time elapsed since the issuance of Disposition 7729/2011 and the experience gained by ANMAT—as well as by regulatory agencies with high-quality standards in the review and registration of biological formulations intended to demonstrate similarity—it is considered essential to have updated guidelines on this matter.
Annex I of the Disposition outlines these requirements, guidelines, and criteria for the comparability exercise of biosimilar medicinal products, while Annex II includes a relevant glossary.
Sincerely,