Guidelines

New decree promotes Argentine-made biosimilar medicines

Home/Guidelines | Posted 10/06/2025

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

Home/Guidelines | Posted 07/04/2025

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

Home/Guidelines | Posted 25/02/2025

In January 2025, the US Food and Drug Administration (FDA) released a draft guidance titled ‘Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products’ [1].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

Home/Guidelines | Posted 06/02/2025

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

Home/Guidelines | Posted 29/10/2024

On 3June 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

Home/Guidelines | Posted 15/10/2024

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

Home/Guidelines | Posted 08/10/2024

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

Home/Guidelines | Posted 23/07/2024

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.

FDA Guidance on Promotional Labelling and Advertising for Biologicals, Biosimilars and Interchangeables

Home/Guidelines | Posted 28/05/2024

The US Food and Drug Administration (FDA) announced on 24 April 2024, the availability of a revised draft guidance for industry entitled ‘Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers Guidance for Industry’.

New decree for the prescription and commercialization of medicines in Argentina

Home/Guidelines | Posted 11/03/2024

Through Decree 63/2024, published on 22 January 2024, in the Official Gazette of the Argentine Republic, progress began on the regulation of the Decree of Need and Urgency (DNU). DNU 70/23 regarding articles related to the prescription of medications and their commercialization. Likewise, work is also being done on upcoming regulations.

FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling

Home/Guidelines | Posted 22/09/2023

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’ [1].

WHO’s revised guideline to safe and effective biosimilar products

Home/Guidelines | Posted 24/02/2023

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 [1]. The updates include the following but are not restricted to these alone and should be read in conjunction with the guidelines [2]:

New FDA guidance on statistical approaches to establishing bioequivalence

Home/Guidelines | Posted 20/01/2023

In December 2022, US Food and Drug Administration (FDA) updated its draft guidance on statistical approaches to establishing bioequivalence [1]. Following this, the public were given 60 days to comment of the draft.

UK updates guidance to allow biosimilars interchangeability

Home/Guidelines | Posted 13/01/2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its 2021 guidance on biosimilars [1] in November 2022 to allow interchangeability between biosimilars if they use the same reference medicinal product (RP).

Guidelines for the regulation of biologicals, biosimilars and radiopharmaceuticals in Brazil

Home/Guidelines | Posted 01/12/2022

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.

FDA Guidance for Industry updates: more meetings with ANDA applicants

Home/Guidelines | Posted 01/12/2022

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.

Turkish guidelines for follow-on biologicals

Home/Guidelines | Posted 27/04/2012

Last update: 23 July 2024

The regulatory body for approval of medicines in Turkey is the General Directorate of Pharmaceuticals and Pharmacy (GDPP). The agency is responsible, under the authority of the Ministry of Health of the Turkish Government, for the registration, marketing approval/authorisation, pricing of pharmaceuticals, legal classification, control of advertisement for pharmaceutical products as well as inspection of pharmaceutical manufacturers, wholesalers and retail pharmacies. The agency is assisted in its tasks by a number of expert committees.

FDA releases new guidance on instructions for use for biologicals

Home/Guidelines | Posted 29/07/2022

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.

Mexican guidelines for biocomparables

Home/Guidelines | Posted 10/02/2012

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.

Argentinian guidelines for similar biological medicines

Home/Guidelines | Posted 03/05/2013

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).

Colombian guidelines for productos bioterapéuticos similares

Home/Guidelines | Posted 19/06/2015

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.

Peruvian guidelines for productos biológicos similares

Home/Guidelines | Posted 24/05/2013

Last updated: 20 May 2022

The regulatory body responsible for approving biological drugs in Peru is the General Directorate of Medicines, Supplies and Drugs (Dirección General de Medicamentos, Insumos y Drogas, DIGEMID) of the Peruvian Ministry of Health (Ministerio de Salud; MINSA).

FDA releases new guidance on bioavailability studies

Home/Guidelines | Posted 29/04/2022

The US Food and Drug Administration (FDA) has released new guidance on submitting bioavailability information for drug products in investigational new drug applications (INDs) and new drug applications (NDAs).

FDA issues draft guidance on immunogenicity labelling

Home/Guidelines | Posted 11/02/2022

The US Food and Drug Administration (FDA) announced on 3 February 2022 the availability of a draft guidance for industry entitled ‘Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling — Content and Format’.

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