The US Food and Drug Administration (FDA) announced on 15 September 2023, the availability of a draft guidance for industry entitled ‘Labeling for Biosimilar and Interchangeable Biosimilar Products’ .
The review article published by Kang H-N et al. in 2023 presents the key updates that have been incorporated in the World Health Organization (WHO) revised guidelines on evaluation of biosimilars adopted by the WHO Expert Committee on Biological Standardization in April 2022 . The updates include the following but are not restricted to these alone and should be read in conjunction with the guidelines :
In December 2022, US Food and Drug Administration (FDA) updated its draft guidance on statistical approaches to establishing bioequivalence . Following this, the public were given 60 days to comment of the draft.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its 2021 guidance on biosimilars  in November 2022 to allow interchangeability between biosimilars if they use the same reference medicinal product (RP).
ANVISA (Agência Nacional de Vigilância Sanitária), the National Health Surveillance Agency of Brazil, published in November 2022 three new guidance documents on the regularization of biological, biosimilar and radiopharmaceutical products.
As of October 2022, US Food and Drug Administration (FDA) has updated four guidances to address new commitments made in the latest Generic Drug User Fee Amendments (GDUFA III) programme. To enhance the ability to have productive discussion about prospective products, the guidances now include provision to permit and remote meetings between FDA and prospective and current abbreviated new drug application (ANDA) applicants.
The US Food and Drug Administration (FDA) has released new guidance on Instructions for Use (IFU) for human prescription drugs and biological products. The guidance is an updated version of a 2019 draft and explains how to create safe and consistent IFUs.
Last update: 22 July 2022
The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). The agency, created in 2001, is a decentralized organ of the Department of Health with technical, administrative and operational autonomy. It is responsible for protecting the Mexican population against sanitary risks, through sanitary regulation, control and promotion.
Last update: 17 June 2022
The regulatory body for approval of medicines in Colombia is INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Colombia’s National Institute of Food and Drug Monitoring. It is the national regulatory agency, a technical-scientific surveillance and control body, which works to protect the individual and collective health of Colombians, through the application of health standards associated with the consumption and use of food, medicines, medical devices and other products subject to health surveillance. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Colombia.
Last update: 24 June 2022
The regulatory body for approval of medicines in Argentina is the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods and Medical Devices; ANMAT).