Tocilizumab biosimilar (Mycenax Biotech)

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended 12 medicines for approval at its February 2026 meeting, including a first-in-class combined mRNA vaccine targeting both seasonal influenza and COVID-19. At the forefront, the CHMP recommended granting a marketing authorization for mCombriax, a combined influenza and COVID-19 mRNA vaccine developed by Moderna. Designed for adults aged 50 and older, mCombriax combines two messenger RNA constructs into a single formulation intended to simplify annual respiratory virus immunisation. The recommendation now goes to the European Commission for final approval. According to World Health Organization data, Europe has recorded more than 281 million COVID-19 cases since the pandemic began, while seasonal influenza alone causes up to 50 million symptomatic cases annually in the European Economic Area (EEA). In oncology, the CHMP recommended a conditional marketing authorisation for Ojemda (tovorafenib) for patients aged six months and older with pediatric low-grade glioma, a non-cancerous brain tumor. The once-weekly oral targeted therapy – developed by Day One Biopharmaceuticals, with ex-US rights licensed to Ipsen SA – aims to expand treatment options beyond surgery and conventional chemotherapy, which can have modest benefit and significant toxicity in young patients. The committee also adopted a positive opinion for Onerji, a levodopa/carbidopa product developed by Tanabe Pharma GmbH, for adults with advanced Parkinson’s disease. In endocrinology, Recordati Rare Diseases-partnered paltusotine, marketed as Palsonify by Crinetics Pharmaceuticals, received a positive opinion for acromegaly, a rare disorder of excess growth hormone. Immunology saw a positive opinion for Rhapsido (remibrutinib) from Novartis for chronic spontaneous urticaria, a long-term itchy rash. For rare inherited immune dysfunction, the CHMP adopted an opinion under exceptional circumstances for Xolremdi (mavorixafor) from X4 Pharmaceuticals, intended for patients aged 12 and older with WHIM syndrome, an ultra-rare condition marked by recurrent infections and increased malignancy risk. The committee also endorsed six biosimilar medicines. Among them was Poherdy, a pertuzumab biosimilar developed by Shanghai Henlius Biotech and partnered with Organon for global ex-China commercialization. If approved, Poherdy would be the first pertuzumab biosimilar endorsed by the CHMP, broadening competition to Roche’s reference product Perjeta in the EU. Poherdy was approved by the US FDA in November 2025. Additional biosimilars recommended include insulin lispro Bysumlog and insulin aspart Dazparda (both from Gan & Lee Pharmaceuticals, and marketed by Sandoz); etanercept Fubelv (by Biosimilar Collaborations Ireland); tocilizumab Tuyory (developed by Gedeon Richter in collaboration with Mochida Pharmaceutical); and teriparatide Zandoriah (by Cinnagen Co. Unipessoal Lda). Final marketing authorizations are subject to European Commission decisions, typically issued within two to three months following CHMP positive opinions.