Guidelines

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.