Provision No. 1741/2025 of the National Administration of Medicines, Food and Medical Technology (“ANMAT”, for its Spanish Acronym) updated the requirements, guidelines and criteria applicable to the comparability exercise of biosimilar medicines (the “Biosimilars”) in the framework of ANMAT Provision No. 7729/2011.
The use of Biosimilars reduces the costs of biotechnological medicinal products, facilitating their availability to a larger number of patients, without compromising safety and efficacy standards.
Provision No. 1741/2025 introduced new requirements related to quality, safety and efficiency that must be met by manufacturers of Biosimilars in the comparability exercise necessary for their registration.
Quality
The manufacturer must demonstrate the consistency and robustness of the manufacturing process by implementing state-of-the-art quality control and quality assurance procedures, in-process controls and process validation. If there is any change during the manufacturing process, these changes should be considered separately from the comparability exercise used to demonstrate biosimilarity with the reference product.
Safety and efficiency
The comparability exercise should also consider the safety and efficiency implications of possible differences between the proposed biosimilar and the selected reference product.
In terms of safety, the regulations establish that minor differences between the proposed biosimilar and the reference product require scientific justification and additional information. Changes intended to improve efficacy compared to the reference product are not compatible with the biosimilarity approach. Differences involving safety advantages could be acceptable.
The provision states that biosimilar manufacturers are responsible for ensuring safety and efficency during products’ life cycle. In addition, it is essential to put in place an adequate system to ensure the specific identification of the biosimilar (i.e. traceability) according to current regulations.
Refusal of biosimilar registration
If it cannot be demonstrated that the product under evaluation and registration and the one selected as reference product are highly similar, ANMAT will refuse the application. In order to register the product, it will be necessary to initiate a new registration process complying with all the requirements established by Provision 7075/11.
