D3.174 - Short-term tolerance of omlyclo, the omalizumab biosimilar

In 2005, the INNOVATE study demonstrated the efficacy of omalizumab (Xolair®, Novartis). Since then, five additional monoclonal antibodies for asthma have been marketed, but no biosimilars had been available. Omlyclo® (Celltrion) is the first biosimilar recently marketed in the respiratory field.

The objative is describe the short-term tolerance of switching from Xolair® to Omlyclo®. 

The first group of adult patients at our center receiving Xolair® for asthma was reviewed. The switch from the originator drug to the biosimilar was performed at the time of the scheduled Xolair® dose. Patients were informed both in the pulmonary service and in the hospital pharmacy department. The Hospital Pharmacy department provided education related to the brand switch of omalizumab, informing patients about the transition to a biosimilar and addressing potential questions. Specific training on the use of the new administration device (pen) was also provided to ensure correct injection technique. A contact channel was made available for reporting possible immediate post-administration reactions, and safety follow-up was conducted through the assessment of injection-site reactions according to CTCAE v5.0. Data were evaluated after the first administration of Omlyclo®, with a follow-up period of one month. 

Fifty patients were included; 30 were women. The mean age was 39.88 years (SD 19.50). The mean duration of prior treatment with Xolair® was 5.55 ± 3.17 years. All patients had an allergic phenotype. Five patients developed grade 1 mild cutaneous lesions without clinical relevance. One patient reported fatigue after the second dose, and no clear causal association was established. One patient experienced general malaise and osteomuscular pain that led to treatment discontinuation. No anaphylactic reactions occurred after the first administration of Omlyclo®.

Short-term tolerance to switching from the originator drug to the biosimilar Omlyclo® was excellent overall, with only mild adverse events observed in a small proportion of patients.