First ever biosimilar of interferon beta-1a approved in Russia

Represents Biocad's third authorized medicine for the treatment of relapsing-remitting multiple sclerosis.

The Ministry of Health (MoH) of the Russian Federation has awarded Biocad marketing authorization for its interferon beta-1a biosimilar, a version of Biogen’s Rebif that is a key component in treatment of relapsing-remitting multiple sclerosis (RRMS) and included in all international recommendations and protocols. Biocad started the development program for interferon beta-1a biosimilar in 2012 and it took almost 5 years to run all the development phases, including pre-clinical/clinical studies and registration. The new biosimilar will be available for Russian patients this year.

Biocad’s interferon beta-1a biosimilar is the only registered biosimilar of Rebif in Russia and worldwide, which was developed in accordance with EMA guidelines. It showed no statistically meaningful difference in pharmacokinetics and pharmacodynamics parameters during Phase I study and proved safety and efficacy equivalence to reference medicine in Phase III study.

Included in the federal list of essential drugs and special reimbursement program for medicines used in rare debilitating diseases, interferon beta-1a is one of the most demanded therapeutic proteins the Russian government reimburses.

Roman Ivanov, the R&D vice-president of Biocad, said: "Interferon beta-1a biosimilar is Biocad's third authorized medicine for treatment of RRMS, which makes our biotechnological company the only manufacturer of both APIs and drug products for all first generation disease-modifying therapies. Moreover, five other drugs for use in MS, including two novel molecules, are in different development phases, supplementing the Biocad’s autoimmune diseases pipeline."