Biocad gets first-ever biosimilar of interferon beta-1a approved in Russia

The Russian Ministry of Health (MoH) has awarded domestic biotech firm Biocad marketing authorization for its interferon beta-1a biosimilar, a knockoff of Merck KGaA's (MRK: DE) 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 says it started the development program for interferon beta-1a biosimilar in 2012 and it took almost five years to run all the development phases, including pre-clinical/clinical studies and registration. The new biosimilar will be available for Russian patients already in 2017.

At present, Biocad says its interferon beta-1a biosimilar is the only registered biosimilar of Rebif in Russia and worldwide, which was developed in accordance with European Medicine Agency 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.