[THE INVESTOR] The U.S. Food and Drug Administration has accepted for review a new Lantus biosimilar developed by U.S.-based Merck Sharp & Dohme with partial funding from Samsung Bioepis, MSD said last Friday.

MSD’s biosimilar drug MK-1293 references Lantus, an insulin-based diabetes treatment originally developed by Sanofi. Samsung Bioepis has contributed to MK-1293’s development as an investment partner to MSD.

 

MK-1293 is already undergoing a marketing authorization review by the European Medicines Agency, as MSD seeks to commercialize the drug in both the U.S. and Europe, the world’s two biggest markets for biosimilar drugs.

Biosimilars refer to cheaper, near-replicas of biologic drugs which have lost patent protection. Sanofi’s formulation patent on Lantus, the company’s top-selling drug, expired last year in the U.S. and Europe.

If approved, MK-1293 is expected to compete against not only Lantus but also a Lantus biosimilar developed by Eli Lilly, which has already secured approval from the FDA and EMA and is nearing commercialization.

MK-1293, also known as SB9, stands as one of Samsung Bioepis’ six biosimilars that reference some of the world’s top biologic drugs -- Enbrel, Remicade, Humira, Avastin, Herceptin and Lantus.

Two of them -- one based on Amgen’s Enbrel and another on Johnson & Johnson’s Remicade -- were approved in Europe earlier this year and have been commercialized in some countries in the region.

Samsung Bioepis’ Humira biosimilar is awaiting marketing approval from the EMA while its two biosimilars referencing Avastin and Herceptin are currently undergoing phase three clinical trials.

Samsung Bioepis is the biosimilars development unit of South Korean electronics giant Samsung Group. Alongside its parent company Samsung BioLogics, a contract manufacturer of biologic drugs, Bioepis is at the center of the conglomerate’s latest push to secure a lead in biopharmaceuticals.

By Sohn Ji-young/The Korea Herald (jys@heraldcorp.com)