Guidelines
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’).
Peru issues decree for the registration of medicines and biological products
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
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
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
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
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
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
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
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
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.
