The European Commission (EC) has approved Celltrion’s Avtozma (CT-P47), a biosimilar referencing Roche’s RoActemra (tocilizumab).
The drug contains the active ingredient tocilizumab and has been authorised to treat all of RoActemra’s approved indications, including moderate to severely active rheumatoid arthritis, active systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis and giant cell arteritis.
A biosimilar, according to the European Medicines Agency, is a biological medicine that is highly similar to one already approved in the EU. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product.
Avtozma, which is Celltrion’s twelfth biosimilar to be approved by the EC, is a recombinant humanised monoclonal antibody designed to inhibit soluble and membrane-bound interleukin‑6 receptors involved in driving inflammatory diseases.
The EC’s decision on the drug was supported by a comprehensive data package and totality of evidence demonstrating Avtozma’s biosimilarity to RoActemra, Celltrion said.
This included results from a late-stage trial in moderate to severely active rheumatoid arthritis, which demonstrated therapeutic equivalence of Avtozma and RoActemra in treating the chronic inflammatory disease that causes pain, swelling and stiffness in joints.
Comparable and sustained efficacy results were observed up to week 52 of the study, and Avtozma was found to be well tolerated with a safety profile comparable to RoActemra.
Additionally, no notable safety issues were identified following the single transition from RoActemra to Celltrion’s drug compared with maintenance groups up to week 52.
Taehun Ha, senior vice president and head of Europe at Celltrion, said the approval “marks a critical step in [the company’s] mission to provide European healthcare systems with affordable, effective solutions for immunological disorders”.
“By leveraging our integrated operations, we strengthen the stability of supply chains and enhance collaboration with European healthcare professionals,” he added.
The approval comes just days after the EC approved Biocon Biologics’ Yesintek, an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat multiple inflammatory diseases.
Yesintek has been authorised to treat certain cases of plaque psoriasis, psoriatic arthritis and Crohn’s disease after demonstrating comparable safety and efficacy to the reference product.