Biosimilars refer to near-replicas of biologic drugs which have lost patent protection. Archigen’s SAIT101 is a biosimilar replication of Rituxan, which generated some $7.3 billion in annual sales last year as one of the world’s top five biologics sold worldwide. Its U.S. patent expires in 2018.

According to the clinical trials register run by the U.S. National Institutes of Health, the study filed for approval seeks to compare SAIT101’s efficacy and safety with those of Rituxan. Also known as MabThera, Rituxan is taken by patients with follicular lymphoma, a form of lymphatic cancer.

Archigen Biotech has also applied for the FDA’s approval for another clinical study in the phase 1 stage, comparing SAIT101’s effects and safety with those of Rituxan among patients with rheumatoid arthritis.

This is not the first time that Samsung has attempted to develop and commercialize a Rituxan biosimilar. Samsung Electronics had begun developing SAIT101 in 2007, but had abandoned its plans in 2011, presumably to realign its business portfolio under Bioepis.

Samsung Electronics had been exploring biosimilar development under its new business division before the formal establishment of Samsung Bioepis in 2012.

Archigen’s revival of SAIT101’s development is said to reflect Samsung Group’s push to further expand its biosimilars portfolio to include those not being pursued by Samsung Bioepis, also a subsidiary of Samsung BioLogics.

Samsung Bioepis currently has six products under development referencing some of the world’s top-selling drugs. Two of them -- one referencing Amgen’s Enbrel and another referencing Johnson & Johnson’s Remicade -- were approved in Europe earlier this year and has begun sales in some countries in the region.

Industry watchers say Archigen appears to be working on bringing to market biosimilar drugs referencing biologics currently unexplored by Samsung Bioepis -- such as Rituxan.

By Sohn Ji-young (jys@heraldcorp.com)