EC Approves Celltrion's Avtozma, a RoActemra Biosimilar, for Inflammatory Diseases

The European Commission (EC) has recently given the green light to Celltrion’s Avtozma (CT-P47), a biosimilar that references Roche’s RoActemra (tocilizumab). This newly approved drug contains tocilizumab as its active ingredient and is designed to treat a range of conditions for which RoActemra has already been authorised. These include moderate to severely active rheumatoid arthritis, active systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis.

A biosimilar, as defined by the European Medicines Agency, is a biological medicine that closely resembles another already approved product within the European Union. This implies that patients can anticipate the same level of safety and efficacy from the biosimilar as they would with the original reference medicine.

Avtozma is an important addition to Celltrion’s portfolio, being the twelfth biosimilar from the company to receive EC approval. It is engineered as a recombinant humanised monoclonal antibody that targets both soluble and membrane-bound interleukin‑6 receptors, which play a significant role in inflammatory diseases.

The EC's approval of Avtozma was underpinned by an extensive data package that reinforced its biosimilarity to RoActemra. This package included findings from a late-stage clinical trial involving patients with moderate to severely active rheumatoid arthritis. The trial results confirmed that Avtozma and RoActemra are therapeutically equivalent in managing this chronic disease, which is characterised by joint pain, swelling, and stiffness.

Throughout the study, equivalent and sustained efficacy outcomes were noted up to the 52-week mark. Avtozma demonstrated a safety profile comparable to that of RoActemra, with no significant safety concerns arising from the transition of patients from RoActemra to Avtozma compared to those who remained on RoActemra for the duration of the study.

Taehun Ha, who serves as the senior vice president and head of Europe at Celltrion, expressed that the approval signifies a pivotal advancement in the company's mission to supply European healthcare systems with cost-effective and efficient treatments for immunological disorders. Ha emphasised the importance of Celltrion’s integrated operations, which not only enhance the stability of supply chains but also foster collaboration with healthcare professionals across Europe.

The EC's approval of Avtozma follows closely on the heels of their approval of Biocon Biologics’ Yesintek, another biosimilar developed to reference Johnson & Johnson’s Stelara. Yesintek has been authorised to address certain cases of plaque psoriasis, psoriatic arthritis, and Crohn’s disease, having shown comparable safety and efficacy to the original Stelara product.

These approvals underline a growing trend towards the acceptance and utilisation of biosimilars within the European market, offering more affordable therapeutic alternatives while maintaining high standards of safety and effectiveness. This not only benefits patients by broadening access to essential medications but also supports healthcare systems in managing costs associated with long-term treatments for chronic diseases.