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 3, 2025
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).
Oct 3, 2025
On 3 October 2025, Celltrion announced that it has launched it 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 extension for the treatment of cytokine release syndrome (CRS) in August 2025.
Oct 2, 2025
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®
Oct 1, 2025
On 1 October 2025, Biocon announced that it has entered into a settlement and licence agreement with Amgen that resolves pending BPCIA patent litigation and permits Biocon’s 1 October 2025 US launch of Bosaya™ and Aukelso™ (denosumab-kyqq), biosimilars to Amgen’s Prolia® and Xgeva® respectively.
Oct 1, 2025
On 1 October 2025, the US Patent Trial and Appeal Board (PTAB) issued its decision in the inter partes review (IPR), filed by Amgen in February 2025 and instituted in July 2025, challenging the validity of BMS’ US patent US11332529 (‘529) relating to methods of treating colorectal cancer using nivolumab (Opdivo®) and ipilimumab (Yervoy®).
Oct 1, 2025
On 1 October 2025, Sandoz’s Erelzi®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in 50mg/mL syringe and pen devices.
Sep 29, 2025
On 29 September 2025, Fresenius Kabi announced that the US Centers for Medicare and Medicaid Services (CMS) assigned a permanent billing code for Conexxence® and Bomyntra®, biosimilars to Regeneron/Bayer’s Prolia® and Xgeva® (denosumab), respectively.
Sep 29, 2025
On 29 September 2025, Gedeon Richter and Hikma Pharmaceuticals announced they have secured FDA approval for Enoby™ (RGP-14-P) and Xtrenbo™ (RGP-14-P) (denosumab-qbde), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.
Sep 29, 2025
On 29 September 2025, Outlook Therapeutics announced that it has completed a Type A Meeting with the FDA to discuss the August 2025 complete response letter (CRL) declining Outlook’s BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.
Sep 29, 2025
On 29 September 2025, Genmab A/S and Merus N.V. announced that they have entered into an agreement for Genmab to acquire all the shares of Merus in an all-cash transaction worth approximately USD 8 billion, with the deal anticipated to close early in the first quarter of 2026.
Sep 29, 2025
On 29 September 2025, Novartis announced that it plans to launch a US direct-to-patient (DTP) platform for Cosentyx® (secukinumab) from 1 November 2025, offering cash-paying patients access to the drug at 55% off the list price.
Sep 29, 2025
On 29 September 2025, Johnson & Johnson announced that the US FDA has approved an indication extension for Tremfya® (guselkumab) for the treatment of severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in children aged six and older, weighing at least 40 kg. J&J submitted the two supplemental Biologics Licence Applications (sBLAs) for these indications in December 2024.
Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.