Russia OKs Biosimilar to Merck KGaA’s Top-Selling MS Drug
The Ministry of Health (MoH) of the Russian Federation has granted marketing authorization to Biocad, a St. Petersburg, Russia-headquartered biotechnology company, for its interferon beta-1a biosimilar to Merck KGaA’s multiple sclerosis drug, Rebif (interferon beta-1a). Rebif, indicated for treating relapsing-remitting multiple sclerosis (RRMS), is a top-selling drug for Merck KGaA with 2016 sales of EUR 1.7 billion ($1.8 billion).
Biocad’s interferon beta-1a biosimilar was developed in accordance with European Medicine Agency (EMA) guidelines. It showed no statistically meaningful difference in pharmacokinetics and pharmacodynamics parameters during Phase I study and proved safety and efficacy equivalence to the reference medicine in Phase III study, according to Biocad.
The interferon beta-1a biosimilar is Biocad’s third authorized drug for treating RRMS. The company has five other drug candidates under development for treating multiple sclerosis in its autoimmune diseases pipeline, including 2 new molecules.
Biocad started the development program for its interferon beta-1a biosimilar in 2012. The company expects to launch the drug this year.
Editor’s note: This story has been updated with the 2016 sales figure for Merck KGaA’s Rebif after Merck KGaA published its 2016 earnings on March 9, 2017.