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On 20 October 2025, Regeneron announced that it has settled its BPCIA litigation with Celltrion in relation to Eydenzelt®/CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg).  Under the terms of the settlement, Celltrion is permitted to launch Eydenzelt® in the US o...

On 17 October 2025, Samsung Biologics announced that its biosimilar operations will be spun off into a new holding entity, Samsung Epis Holdings, after the proposal was approved by shareholders at an Extraordinary General Meeting.

Following the spin-off, Samsung Biol...

In a significant breakthrough, the Australian Pharmaceutical Benefits Advisory Committee (PBAC) has recommended a broad, multi-indication listing for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) in advanced or metastatic cancers.  The novel recommendation is the result...

On 16 October 2025, Biocon Biologics announced that it is has expanded its collaboration with US-based non-profit pharmaceutical firm Civica, Inc. to supply a new insulin glargine medicine in the United States.

Under the exclusive agreement, Biocon Biologics will man...

On 16 October 2025, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the highlights of its October 2025 meeting, including a positive opinion for an indication extension to J&J/Janssen’s Tremfya® (guselkumab).  The recommend...

On 16 October 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), has entered exclusive licence agreements with Actor Pharmaceuticals and Uru...

Pearce IP’s CEO, Naomi Pearce, discusses trends in preliminary injunctions in Australian life sciences patent cases with Head of Litigation (Australia), Helen Macpherson, following the recent Federal Court refusal of Regeneron’s and Bayer’s patent PI application against San...

On 14 October 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has approved Reliance Life Sciences’ Phase I/III clinical trial for its biosimilar nivolumab (R-TPR-067 or RLS-Nivolumab).

On 13 October 2025, Regeneron announced that it has been notified by Catalent Indiana, LLC, which was acquired by Novo Nordisk and is the manufacturer filler included in the supplemental BLA for Regeneron’s high dose (8mg) formulation of Eylea® (aflibercept), that Catalent ...