GaBI - Generics and Biosimilars Initiative

HHS push to ‘genericize’ biosimilars sparks backlash

HHS push to ‘genericize’ biosimilars sparks backlash The US Department of Health and Human Services (HHS), through the US Food and Drug Administration’s (F...

Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows
https://gabionline.net/biosimilars/news/canada-approves-multiple-denosumab-and-ustekinumab-biosimilars-as-global-competition-grows

Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows

Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows Health Canada has approved several new biosimilars referencing Amgen’s Prolia/Xgeva (denosumab) and Janssen’s Stelara (ustekinumab) in the first ha...

HHS push to ‘genericize’ biosimilars sparks backlash
https://gabionline.net/biosimilars/research/hhs-push-to-genericize-biosimilars-sparks-backlash

Drug repurposing initiative may signal change in regulatory approach

FDA’s Drug Repurposing Initiative Signals a Shift in Regulatory Strategy | JD Supra The U.S. Food and Drug Administration (FDA) recently launched a drug repurposing initiative that may signal a shift in how the Agency approaches...

WHO releases list of device regulators eligible for listed authority status

WHO advances global regulatory cooperation with first interim list of regulatory authorities for medical devices On 14 July 2026, the World Health Organization (WHO) published its first interim list of regulatory authorities for medical devices, known as transitional WHO Listed Authorities (tWLAs). The list marks an important milestone in strengthening global regulatory cooperation and supporting regulatory re...

Congress pushes biosimilar bills as interchangeability concerns linger

Congress pushes biosimilar bills as interchangeability concerns linger US Congress is fast‑tracking multiple biosimilar bills this summer, but a new analysis warns that eliminating interchangeability requireme...

FDA approves Zimrixby (rituximab) and Garzulys (insulin aspart) biosimilars
https://gabionline.net/biosimilars/news/fda-approves-zimrixby-rituximab-and-garzulys-insulin-aspart-biosimilars

NIBRT designated as WHO regional training centre for biomanufacturing in the European region

NIBRT Designated as WHO Regional Training Centre for Biomanufacturing in the European Region - National Institute for Bioprocessing Research PRESS RELEASE NIBRT has been designated by WHO as the Regional Training…

La ANVISA de Brasil actualiza las directrices sobre los estudios farmacocinéticos de los biosimilares

La ANVISA de Brasil actualiza las directrices sobre los estudios farmacocinéticos de los biosimilares La Agencia Nacional de Vigilancia Sanitaria de Brasil (ANVISA) publicó el 29 de junio de 2026 la Nota Informativa 1/2026/GGBIO, que ofrece aclaraci...