Read our latest updates & insights

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...

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.  The FDA approval follows J&J’s submission of the sBLA for...

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.

The agreement follows the...

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).

AVT23 (also known as ADL-018) was developed by Alvotech in col...

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.  The identities of the biosimilars have not yet been disclosed but they are ...

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.

The...

On 3 October 2025, IP Australia delivered its decision in Samsung Bioepis’ opposition to the grant of Janssen’s AU2019346134 relating to a method of treating ulcerative colitis with Stelara® (ustekinumab).  IP Australia ruled that the patent application was invalid for lack...

On 3 October 2025, Celltrion announced that it has launched its intravenous formulation of Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in the United States.  Avtozma® IV is indicated for all reference indications, with the FDA approving an indication exte...

On 2 October 2025, Formycon announced that it and its licence partners, Klinge Biopharma and Valorum Biologics, have entered a settlement and licence agreement with Regeneron to resolve all US patent disputes relating to FYB203/Ahzantive®, biosimilar to Regeneron’s Eylea® (...