Researchers Report on Biosimilar Interferon Beta-1A in Treating MS

During the fourth congress of the European Academy of Neurology, held in Lisbon, Portugal, from June 16 to 19, researchers reported on CinnaGen’s biosimilar interferon beta 1A drug, CinnoVex. The biosimilar, approved in Iran, Russia, Syria, and Armenia, references Avonex and is used in the treatment of multiple sclerosis (MS). The researchers reported on the efficacy and safety of the biosimilar versus its reference in Russian patients with relapsing-remitting MS (RR MS).

The study included 92 patients with RR MS who were treated with the biosimilar, and 59 patients who were treated with the reference. Safety and efficacy were evaluated after 1 year of treatment. For the efficacy assessment, annual relapse rate (ARR), disability progression, and the presence of new lesions visible on MRI assessment were all analyzed. Adverse events (AEs) were analyzed for the safety assessment.

At 1 year, write the authors, there were no significant differences in baseline characteristics between the 2 groups. Reduction in ARR from baseline was similar between the 2 groups; the patients receiving the biosimilar reduced their ARR to 0.36 at 1 year from 0.74 at baseline, and the patients receiving the reference reduced their ARR to 0.38 at 1 year from 0.81 at baseline.

Additionally, 91% of patients receiving the biosimilar and 88% of patients receiving the reference had no disability progression during the treatment period, and 16% and 14% of the patients in the 2 groups, respectively, were free from new lesions.

The most frequently reported AEs in both groups were flu-like symptoms (51% in the biosimilar group and 58% in the reference group) and local reactions (4% in the biosimilar group and 3% in the reference group).

The authors concluded that the results of the study suggest that the biosimilar product has equivalent safety and efficacy to the reference in treating patients with RR MS.

Reference

Devlikamova F, Dykhanov A, Khabirov F, Khaybullin T, Granatov E. Interferon beta-1A biosimilar in patients with relapsing remitting multiple sclerosis. Presented at the European Academy of Neurology Congress, June 16-19, 2018; Lisbon, Portugal. Abstract POD407. https://ipp-ean18.netkey.at/index.php?p=recorddetail&rid=77931c3b-9acc-475c-8cf4-5e2024d0095d&t=browsesessions#ipp-record-d9da5197-df7c-4f04-9181-4e8108a8b93c.