News
Canada eliminates phase III trial requirement for biosimilar approvals
<p>Health Canada has eliminated Phase III trial requirements for biosimilars, prioritizing analytical studies over large clinical trials to accelerate market access and reduce ...
FDA approves first golimumab biosimilars Immgolis and Immgolis Intri
<p>On 18 May 2026, the US Food and Drug Administration (FDA) approved Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi), marking the first interchangeable biosimilars to ...
House Bill aims to crack down on China biotech deals
<p>A bipartisan House bill proposed on 2 June 2026 would require government screening of US investments in Chinese biotechnology, following two ...
EMA recommends approval for ranibizumab biosimilar Vislyfa
<p>Following the European Medicines Agency’s (EMA) positive opinion of Rexatilux ranibizumab biosimilar in April 2026, on 21 May 2026, the EMA’s Committee for Medicinal Products for Human Use ...
FDA updates draft biosimilar guidance, signalling greater flexibility for developers
<p>In March 2026, the US Food and Drug Administration (FDA) released a revised draft guidance aimed at streamlining biosimilar development and clarifying the agency’s current ...
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