Celltrion to Start Phase 1 Trial of Omalizumab Biosimilar, CT-P39

Republic of Korea—based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.

Omalizumab, developed by Novartis in partnership with Genentech, is a monoclonal antibody approved by the FDA to treat asthma and chronic idiopathic urticaria. The compound patent for the biologic, according to Securities and Exchange Commission filings, expired in 2018. However, Novartis, according to its annual report in 2018, holds additional patents on syringe formulations that will not expire in the US or EU markets until 2021 and 2024.

Celltrion says that it began development of its biosimilar in December 2018 and added that it hopes to be the first developer to launch a biosimilar of the molecule. In particular, Celltrion says that it is focused on the US market, which accounts for approximately 70% of the branded drug’s global sales.

The phase 1 trial will enroll an estimated 171 healthy adult volunteers for a randomized, double-blind, 3-arm, parallel-group, single-dose study to compare the pharmacokinetics and safety of EU-licensed Xolair, US-licensed Xolair, and the proposed biosimilar. The trial is expected to be completed in August 2020.

In addition to Celltrion, several other biosimilar developers are targeting omalizumab; Glenmark announced its phase 1 study of proposed biosimilar GBR 310 in 2018, and Sorrento Therapeutics has completed a phase 2 and phase 3 study of its STI-004. Additionally, Biosana this year received permission from Australian regulators to initiate a phase 1 trial of its BP001.

Meanwhile, Novartis has been developing another product that could help it retain a hold on the market for utricaria. In 2018, the drug maker announced that its ligelizumab would advance to phase 3 trials for the treatment of chronic spontaneous urticaria after it demonstrated a clear dose-response relationship and improvements over omalizumab.