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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...

On 9 October 2025, New Zealand’s Medsafe approved Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), in vial and pre-filled syringe presentations, making Afqlir® the first aflibercept biosimilar approved in New Zealand.

Sandoz’s aflibercept b...

On 9 October 2025, The Hague District Court published its decision in legal proceedings between Samsung Bioepis and Regeneron in relation to Regeneron’s Dutch equivalents of European patents EP 2 364 691 and EP 1 183 353, covering formulations of aflibercept.  The Court fou...

On 8 October 2025, judgment was published in patent infringement proceedings brought by Regeneron/Bayer in the UK seeking to prevent Samsung Bioepis and Formycon/Klinge from launching biosimilars to Regeneron/Bayer’s Eylea® (aflibercept) in the UK after the November 2025 ex...

Between 18 and 23 September 2025, the US Patent Trial and Appeal Board (PTAB) issued final decisions invalidating Johns Hopkins University’s 11,339,219 (IPR2024-00625), 11,649,287 (IPR2024-00647), 11,629,187 (IPR2024-00649) and 11,634,491 (IPR2024-00650) in four inter parte...