Guidelines
Canada poised to remove requirement for Phase III trials for biosimilars
On 10 June 2025, Health Canada issued ‘Guidance document: Information and submission requirements for biosimilar biologic drugs (2025 – Revised draft)’ [1]. Key to this new draft is the proposal to remove the requirement for biosimilar manufacturers to prove the safety and efficacy of their product through phase III clinical trials, see Table 1.
European position paper on AI in medicinal product lifecycle
At the end of 2024, the European Medicine’s agency (EMA) published a reflection paper on ‘The use of Artificial Intelligence (AI) in the medicinal product lifecycle,’ [1]. This was based on the draft guidance issued in 2023 [2].
New decree promotes Argentine-made biosimilar medicines
Argentina promotes local biosimilar production through Decree 1741/2025 to lower treatment costs and reduce import dependence. The move aims to improve healthcare access but faces challenges in infrastructure and quality control. Experts support the initiative.
Advances in EMA plans to streamline biosimilar assessment
On 1 April 2025, the European Medicines Agency (EMA) published a ‘draft reflection paper on a tailored clinical approach in biosimilar development’ [1], which explores potential improvements to the development and evaluation of biosimilar medicines while maintaining the European Union’s (EU) stringent safety standards.
FDA issues guidance on AI use in drug and biologicals regulatory decision making
In January 2025, the US Food and Drug Administration (FDA) released a draft guidance titled ‘Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products’ [1]. This is the first guidance the agency has issued on the use of artificial intelligence (AI) for the development of drug and biological products.
ICH adopts Good Clinical Practice Guideline for clinical trials
In January 2025, the International Council for Harmonisation (ICH) announced the adoption of its E6(R3) guideline, which aims to harmonize the framework for conducting clinical studies [1, 2].
Regulatory update for post-registration of biological products in Brazil
On 3 June 2024, Resolution RDC No. 876 was published in Brazil in the Official Journal of the Union (DOU) [1], modifying the current regulations regarding the post-registration of biological products (RDC 413/2020).
New regulations in Brazil for the registration of biosimilars
In June 2024, Resolution RDC No. 875 was published in Brazil in the Official Journal of the Union (DOU) [1], modifying the current regulation regarding the registration of biological products (RDC 55/2010).
FDA releases Guidance for Industry on Real-World data
In July 2024, the US Food and Drug Administration (FDA) provided recommendations to drugmakers for assessing the use of electronic health records and medical claims data to support their applications.
FDA interchangeable biosimilars guidance update on revised approach to switching studies
In June 2024, the US Food and Drug Administration (FDA) issued a draft guidance for industry ‘Considerations for Demonstrating Interchangeability with a Reference Product: Update’ [1]. This draft guidance outlines considerations for switching studies to demonstrate a biological product's interchangeability with a reference product.
