Menu

Guidelines

Regulation-V13H16

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).

136 AA011035

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.

Interchangeability V18K30

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In June 2024, the US Food and Drug Administration (FDA) issued a draft guidance for industry ‘Considerations for Demonstrating Interchangeability with a Reference Product: Update’ [1]. This draft guidance outlines considerations for switching studies to demonstrate a biological product's interchangeability with a reference product.

19646665_l

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The US Food and Drug Administration (FDA) announced on 24 April 2024, the availability of a revised draft guidance for industry entitled ‘Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and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

ANMAT logo V13E03

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.

Label prescription drugs

FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling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The US Food and Drug Administration (FDA) announced on 15 September 2023, the availability of a draft guidance for industry entitled ‘Labeling for Biosimilar and Interchangeable Biosimilar Products’ [1].

Guidance V13F21

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]:

130 AA008570

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.

Interchangeability V18K30

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).

ANVISA V22A14

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.