Gedeon Richter PLC. , Dorog

Amgen filed three separate BPCIA patent infringement lawsuits in late June 2025 against companies developing denosumab biosimilars, including Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon.

The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for USYMRO (ustekinumab), Bio-Thera Solutions' biosimilar referencing Stelara.

• Gedeon Richter has submitted a marketing authorization application to the European Medicines Agency for its tocilizumab biosimilar (RGB-19), developed jointly with Mochida Pharmaceutical. • The application includes comprehensive data from Phase I PK/PD studies in healthy volunteers and Phase III efficacy trials in rheumatoid arthritis patients, demonstrating similarity to RoActemra® across all parameters. • If approved, the biosimilar will expand access to this IL-6 inhibitor for treating rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, cytokine release syndrome, and COVID-19 across Europe.

• A first-of-its-kind daily pill for endometriosis, relugolix combination therapy (Ryeqo), has been approved for NHS use in England after initially being rejected by Nice. • The breakthrough treatment works by blocking hormones that contribute to endometriosis while providing hormone replacement, offering a more convenient alternative to injectable treatments for approximately 1,000 patients annually. • Endometriosis affects 1.5 million women in the UK, causing debilitating pain and fertility issues, with diagnosis typically taking nine years from symptom onset.

• The global bipolar depression market is projected to experience significant growth through 2034, driven by increasing prevalence, with the United States accounting for approximately 85% of the market share across major regions. • Several pharmaceutical companies including NeuroRx, COMPASS Pathways, and Intra-Cellular Therapies are advancing novel treatments, with Johnson & Johnson's recent $14.6 billion acquisition of Intra-Cellular Therapies highlighting industry confidence in the sector. • Among current therapies, CAPLYTA (lumateperone) is expected to achieve the highest market share by 2034, while emerging treatments like NRX-100/101 and COMP 360 (psilocybin) show promise for addressing unmet needs in bipolar depression management.

• AbbVie and Gedeon Richter have entered a new agreement to discover and develop novel targets for neuropsychiatric conditions, building on nearly two decades of partnership. • Richter will receive an upfront payment of $25 million and is eligible for future milestone payments and royalties, while AbbVie gains commercialization rights outside specific European markets. • The collaboration aims to address the significant unmet needs in neuropsychiatric disorders, which affect over 20% of adults in the United States. • The partnership highlights the ongoing efforts to innovate in CNS therapies, leveraging Richter's discovery platform and AbbVie's global reach.