No Results Found
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
The page you requested could not be found. Try refining your search, or use the navigation above to locate the post.
Oct 10, 2025
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.
Oct 9, 2025
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.
Oct 9, 2025
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).
Oct 9, 2025
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.
Oct 9, 2025
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.
Oct 8, 2025
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
Oct 7, 2025
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)
Oct 7, 2025
On 7 October 2025, Johnson & Johnson announced that the FDA has approved Simponi® (golimumab) for treating children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg.
Oct 6, 2025
On 6 October 2025, Alfresa Holdings announced that it has entered into agreements with two other Japanese companies, Kidswell Bio Corporation and Chiome Bioscience Inc., to jointly develop biosimilars for unnamed specified products in Japan.
Oct 6, 2025
On 6 October 2025, Alvotech announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT23, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).
Oct 6, 2025
On 6 October 2025, Hikma Pharmaceuticals and Celltrion Inc, announced that they have entered exclusive licensing agreements for 6 biosimilars, across the Middle East and North Africa (MENA) region.
Oct 3, 2025
On 3 October 2025, Pharmacy Times reported that CSPC Pharmaceutical Group’s SYSA1902 has been shown in a phase 3 study to be clinically equivalent to its reference product, Janssen’s Stelara® (ustekinumab) for the treatment of moderate to severe plaque psoriasis.
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.