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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.

FDA new and revised guidances for complex generics

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

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

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

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.