News
Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows
<p>Health Canada has approved several new biosimilars referencing Amgen’s Prolia/Xgeva (denosumab) and Janssen’s Stelara (ustekinumab) in the first half of 2026, significantly expanding ...
HHS push to ‘genericize’ biosimilars sparks backlash
<p>The US Department of Health and Human Services (HHS), through the US Food and Drug Administration’s (FDA), is launching an ...
ANVISA and DINAVISA sign MoU to strengthen border surveillance and regulatory cooperation
<p>Brazil’s National Health Surveillance Agency (ANVISA) and Paraguay’s National Directorate of Health Surveillance (DINAVISA) signed a new Memorandum of Understanding (MoU) on 20 August 2026, ...
FDA approves Zimrixby (rituximab) and Garzulys (insulin aspart) biosimilars
<p>Two biosimilars—Zimrixby (rituximab-cdxx) and Garzulys (insulin aspart-fsan)—received US Food and Drug Administration (FDA) approval in July 2026, expanding treatment options in oncology, ...
Biosimilar race: Sandoz expands pipeline with Henlius, Teva secures ocrelizumab candidate
<p>Two major strategic collaborations announced in July and August 2026 underscore the intensifying race to capture value from the upcoming biosimilar wave, as Sandoz broadens ...
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