Mycenax’s Actemra biosimilar edges closer to approval

Actemra, marketed as RoActemra in the EU, is approved for immunology and musculoskeletal disorders including rheumatoid arthritis.

The double-blinded, randomized, 3-arm parallel study was conducted in Australia and New Zealand. Three randomized groups of 190 healthy subjects received single intravenous dose (4 mg/kg) of either LusiNEX or originator products (EU-RoActemra or US-Actemra). After dosing, study participants underwent an 8-week assessment period to evaluate its bioequivalence in terms of pharmacokinetic (PK), safety and tolerability.

The study’s primary endpoint was the area under the concentration-versus-time curve calculated from start of the infusion until infinity (AUC 0-inf). The study’s prespecified bioequivalence margin was 80% to 125%.

The results demonstrated that LusiNEX met its primary endpoint in PK comparison (AUC0-inf). The geometric mean ratio was 96.60 % (90 % CI, 92.33 % – 101.06 %) and 95.58 % (91.30 % – 100.07 %) compared with EU and US originators, respectively. Other PK parameters and the types and incidence rates of adverse events observed with LusiNEX were also comparable to those seen with the originator products.

"We are planning to apply for the scientific advises to European Medicines Agency and Japan Pharmaceuticals and Medical Devices Agency in the first quarter of 2019 to finalise the multinational phase 3 study design with the goal of being granted for both intravenous and subcutaneous dosage forms," said Karen Wen, president at Mycenax Biotech.

Actemra is a recombinant humanized anti-IL-6R monoclonal antibody for injection. Interleukin-6 (IL-6) triggers its signaling system through binding to 80 kDa transmembrane IL-6 receptor (IL-6R). After binding to IL-6R, the complex consisting of IL-6 and transmembrane IL-6R associates with signal-transducing molecule gp130, resulting in the activation of downstream signaling events via Janus kinase (JAK) in target cells. Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and therefore inhibits the inflammatory signaling that implicated in the pathogenesis of diseases.

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