Guidelines

US guidance to remove biosimilar comparative efficacy studies

On 29 October 2025, the US Food and Drug Administration (FDA) announced a move to reduce development times and expenditure for biosimilars.

New guidance for biologicals in Pakistan and Hong Kong’s independent drug regulatory authority

In July 2025, the Drug Regulatory Authority of Pakistan (DRAP) published guidance on the requirement for clinical trials or biosimilarity studies to support the registration of locally manufactured biological medicines. This follows news that in June 2025, the Hong Kong Department of Health released a timetable for launching its Centre for Medical Products Regulation (CMPR) and is now starting to independently approve medical products.

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 This was based on the draft guidance issued in 2023 [2].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In January 2025, the US Food and Drug Administration (FDA) released a draft guidance titled ‘Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products’ [1].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.

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

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’.

Italy publishes new guidelines on pricing and reimbursement of generics and biosimilars

The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) announced on 30 December 2020 that it had published new guidelines for the pricing and reimbursement of medicines, which include a new streamlined procedure for generics and biosimilars.

New decree for the prescription and commercialization of medicines in Argentina

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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’.

Guide for the comparability assessment of biological drugs in Colombia

Biological drugs have been a breakthrough in the treatment of many diseases, but their cost is usually high, so the development and approval of similar biotherapeutic products has greatly facilitated access for patients, especially in developing countries. That is why Colombia issued guidelines including all these similar biotherapeutic products [1].

FDA issues new guidance on biosimilar development and the BPCI Act

The US Food and Drug Administration (FDA) has published final guidance on ‘Questions and Answers on Biosimilar Development and the BPCI Act’ and draft guidance on ‘New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)’.

Decree signed in Costa Rica for the use of generic name in medicines

The Costa Rican Ministry of Health has been pushing since 2018 the decree of the 'Regulations for the Prescription and Dispensing of Medicines in Conformity with their International Nonproprietary Name (INN)’ for the Costa Rican private market [1].

Biosimilar User Fee Act (III) performance goals letter published

In mid-September 2021, the US Food and Drug Administration (FDA) released the Performance Goals Letter for the Biosimilar User Fee Act (BsUFA) III (FY2023 – FY2027) [1].

FDA updates generics guidance due to COVID-19 pandemic

On 8 September 2021, the US Food and Drug Administration (FDA) revised its questions and answers guidance on generic drug development and abbreviated new drug application (ANDA) submissions during the COVID-19 public health emergency.

WHO guidelines on pharmaceutical pricing policies

The World Health Organization (WHO) has issued a new plain language summary on country pharmaceutical pricing policies, as part of its efforts to promote the use of high-quality generic and biosimilar medicines.

Mexico introduces new decree on health regulation

On 31 May 2021, COFEPRIS published the Decree which specifies changes to the Health Supplies Regulation (Reglamento de Insumos para la Salud, RIS). These changes, most of which are effective immediately, streamline administrative processes, focus on health surveillance, and promote openness and innovation in global health inputs.

UK’s MHRA updates its guidance on licensing biosimilars

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on biosimilars, softening the rules in order to enable these products to reach the UK market faster.

Draft decree for prescribing generics in Costa Rica

The decree on the 'Regulation for the Prescription of Medicines in Conformity with their International Nonproprietary Name (INN) for the Costa Rican private market' has been promoted by the Ministry of Health since 2018 and establishes that all doctors, dentists and obstetricians are obliged to prescribe medicines by their international non-proprietary name or generic name and not by brand name. The regulation also adds that doctors will be able to include the brand name of the medicine in the prescription if there are 'clinico-pharmacological reasons' that justify recommending that product.

NICE recommends additional biologicals for rheumatoid arthritis

The National Institute for Health and Care Excellence (NICE), which publishes clinical guidance for England, has recommended the use of new biological drugs for the treatment of moderate rheumatoid arthritis. The treatments have become available thanks to biosimilars, which have drastically reduced costs to the National Health Service (NHS) in England.

A new decree modifies several aspects of the regulatory approval system for biosimilars in Mexico

On 31 May 2021, the Mexican President published on the Federal Official Gazette a major amendment to the Secondary Regulations for Health Supplies (Reglamento de Insumos para la Salud, ‘RIS’) (‘Decree’).