Guidelines

Guide for the comparability assessment of biological drugs in Colombia

Home/Guidelines | Posted 17/12/2021

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

Home/Guidelines | Posted 19/11/2021

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(FDA) has published final guidance on ‘Questions and Answers on Biosimilar Development and the BPCI Act’ and draft guidance on ‘New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3)’.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

Home/Guidelines | Posted 29/10/2021

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

Home/Guidelines | Posted 22/10/2021

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

Home/Guidelines | Posted 01/10/2021

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

Home/Guidelines | Posted 24/09/2021

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

Home/Guidelines | Posted 27/08/2021

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

Home/Guidelines | Posted 16/07/2021

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

Home/Guidelines | Posted 09/07/2021

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

Home/Guidelines | Posted 02/07/2021

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

Home/Guidelines | Posted 25/06/2021

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’).

Peru issues decree for the registration of medicines and biological products

Home/Guidelines | Posted 21/06/2021

On 10 January 2021, the Peruvian Ministry of Health (Ministerio de Salud del Perú, MINSA), which is in charge of leading the National and Decentralised Health System, the policy for the universal health assurance and the policies and intersectoral actions on social determinants, published in the Official Gazette Diario Oficial El Peruano the supreme decree 002-2021-SA that approves the regulation for the Conditional Health Registration of Medicines and Biological Products.

FDA issues final guidance on BCS-based biowaivers

Home/Guidelines | Posted 11/06/2021

The US Food and Drug Administration (FDA) has published final guidance on ‘M9 Biopharmaceutics Classification System (BCS)-Based Biowaivers’. The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

FDA guidance on generic drug development during COVID-19

Home/Guidelines | Posted 21/05/2021

The US Food and Drug Administration (FDA) has released guidance on generic drug development and the submission of abbreviated new drug applications (ANDAs) during COVID-19, which explains how manufacturers can overcome issues caused by the pandemic.

UK’s MHRA publishes guidance on licensing biosimilars

Home/Guidelines | Posted 19/02/2021

In the wake of Brexit, which took effect on 1 January 2021, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new biosimilars pathway for the UK.

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

Home/Guidelines | Posted 29/01/2021

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.

FDA increases transparency of biosimilar applications

Home/Guidelines | Posted 22/01/2021

The US Food and Drug Administration (FDA) has made changes to the review of its Biologics License Applications (BLAs) in order to improve transparency and communication.

US guidance on proprietary names

Home/Guidelines | Posted 15/01/2021

The US Food and Drug Administration (FDA) issued a guidance for industry on best practices in developing proprietary names for prescription drugs, in December 2020 [1].

Biosimilar User Fee Act reauthorization

Home/Guidelines | Posted 11/12/2020

The US Food and Drug Administration (FDA) Biosimilar User Fee Act (BsUFA) is due to be reauthorized for the second time (BsUFA III) in 2022. BsUFA allows FDA to collect fees from companies that are developing biosimilar and interchangeable products.

FDA issues Q & A on biosimilars

Home/Guidelines | Posted 04/12/2020

The US Food and Drug Administration (FDA) issued draft Questions and Answers (Q & A) on biosimilars development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) in November 2020.

FDA new and revised guidances for complex generics

Home/Guidelines | Posted 27/11/2020

The US Food and Drug Administration (FDA) has announced new and revised product-specific guidances to support the development and approval of safe and effective complex generic drug products.

UK releases post-Brexit biosimilar guidelines

Home/Guidelines | Posted 06/11/2020

The UK has left the European Union (EU) and the exit transition period ends in January 2021. At this point, the regulation of medicines and devices will be transferred to the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This move away from EU regulation will involve some significant changes.

FDA’s new MAPP explains route for changing ownership of generic drug applications

Home/Guidelines | Posted 25/09/2020

The US Food and Drug Administration (FDA) recently issued a new Manual of Policies and Procedures (MAPP) which outlines how the Office of Generic Drugs (OGD) will process requests to transfer ownership of generic drug applications, and how it will update the Orange Book to reflect those changes.

Center for Biologics Evaluation and Research to regulate biological master files

Home/Guidelines | Posted 04/09/2020

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is now responsible for administering master files for biological drugs, which could create some challenges for biological manufacturers.

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