Celltrion Inc

Celltrion's three biosimilar candidates—Eydenzelt (aflibercept), Stoboclo and Osenvelt (denosumab), and Avtozma (tocilizumab)—received positive opinions from the CHMP. These biosimilars aim to expand access to biologic treatments in skeletal-related disorders, ophthalmology, and immunology across Europe.

Celltrion received EU approval recommendations for four biosimilars: Eydenzelt, Stoboclo, Osenvelt, and Avtozma. These products treat retinal disorders, bone complications, osteoporosis, and autoimmune diseases. CHMP recommendations will be referred to the European Commission for final approval.

Celltrion received positive CHMP opinions for three biosimilars: Avtozma (tocilizumab), Eydenzelt (aflibercept), and Stoboclo/Osenvelt (denosumab). These biosimilars are recommended for various conditions, including RA, sJIA, pJIA, GCA, wet AMD, DME, osteoporosis, and cancer-related bone complications. The EC will decide on final marketing authorizations, aiming to complete an 11-product portfolio by 2025 and expand to 22 biosimilars by 2030.

Celltrion received CHMP recommendations for European market authorization for four biosimilars: Avtozma (Actemra biosimilar), Eydenzelt (Eylea biosimilar), and two Prolia-Xgeva biosimilars, Stoboclo and Osenvelt. These approvals strengthen Celltrion's global market position, targeting 11 biosimilar products by 2025.

Celltrion received CHMP approval recommendation for four biosimilars: AVTOZMA, EYDENZELT, STOBOCLO, and OSENVELT. This advances Celltrion's goal of an 11-product portfolio by 2025, strengthening autoimmune disease treatments and expanding into bone and ophthalmic diseases. The CHMP's recommendation significantly influences EMA approval.

A French study found stable patient satisfaction after switching to the high-concentration, citrate-free adalimumab biosimilar CT-P17. More patients previously treated with a biosimilar reported increased satisfaction compared to those switching from the reference product. Patient education and shared decision making were important to treatment satisfaction.

Alvotech and Advanz Pharma submitted a European marketing application for a golimumab biosimilar, while Celltrion secured Korean approval for denosumab biosimilars. Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar expected to launch post-Opdivo's patent expiry.

CT-P47, a tocilizumab biosimilar, showed similar efficacy, pharmacokinetics, safety, and immunogenicity to reference tocilizumab in a phase 3 study. Presented at ACR Convergence 2024, the study involved 471 RA patients, demonstrating comparable clinical activity and safety profiles up to Week 52.

Big pharma's patent cliff presents a $200 billion opportunity for biosimilar developers, especially with biologics. Five companies—Alvotech, Biocon Biologics, Celltrion, Formycon, and Samsung Bioepis—are highlighted for their biosimilar developments and partnerships, aiming to capitalize on this market shift. The biosimilar market is projected to grow significantly, reaching $150.26 billion by 2033, driven by FDA regulations and demand for affordable treatments.

Amgen seeks to consolidate four pending BPCIA litigations against biosimilar companies in New Jersey federal court. The MDL Panel issued a briefing schedule on Amgen's motion to transfer, with responses due on December 9. Judge O'Hearn set a trial date for Amgen's case against Celltrion on April 7, 2025.