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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 ...

On 12 October 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has requested Alkem subsidiary, Enzene Biosciences, to revise its proposed Phase III clinical trial protocol for biosimil...

On 10 October 2025, Celltrion announced that the FDA has approved Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), for treating nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy.  The launch...

On 9 October 2025, New Zealand’s Medsafe approved Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in vial and pre-filled syringe presentations, making Steqeyma® the first ustekinumab biosimilar approved in New Zealand.

Celltrion’s Steqeyma® has...

On 9 October 2025, Bio-Thera Solutions announced that it has entered an exclusive commercialisation and licence agreement for Canada with Intas Pharmaceuticals in relation to BAT2506, biosimilar to J&J’s Simponi® (golimumab).

This expands the existing partnership...