South Korea’s leading biosimilar manufacturers are gearing up to tap into Europe’s anti-cancer drugs market with their recently developed biosimilars of a number of blockbuster chemotherapy drugs whose patents are nearing to expire or are already expired. Such a move comes after Korean biotechnology companies have focused on developing replicas of autoimmune disease treatments that are effective in mainly curing rheumatoid arthritis for the past few years.

According to multiple industry sources on Monday, Samsung Bioepis Co., a biotechnology research and development unit of Samsung Group, is expected to apply for marketing approval for SB3 - a biosimilar of breast cancer treatment Herceptin - in Europe this month. Since the patent of Herceptin in Europe expired in 2014, Mylan N.V. of the United States and Biocon Ltd. of India have applied for sales approval of their own replicas of Herceptin in Europe last month. Herceptin is a blockbuster drug that raised $6.8 billion in global sales last year.

Samsung Bioepis is also in its final stage of developing a biosimilar of Avastin, a treatment for colorectal cancer, while Archigen Biotech Ltd., a biosimilar developer jointly invested by Samsung BioLogics Co. and AstraZeneca PLC, has been developing a biosimilar of hematological cancer treatment Rituxan, placing Samsung Group’s bio pharmaceutical units to be in front in developing replicas of key anti-cancer treatments that are nearing patent expiration.

Another leading Korean biopharmaceutical company Celltrion Inc. has positioned itself closer to making entry into Europe’s anti-cancer drugs market. It has already applied for approval to sell Truxima, a biosimilar of hematological cancer treatment Rituxan, in Europe in October last year. The company expects to receive green light from the European authority within this year, considering that it normally takes about one year to get approval from application. Celltrion is optimistic about tapping into the European market as it has already received marketing approval for Herzuma, a biosimilar of breast cancer treatment Herceptin, in Korea.

According to industry observers, Korean biosimilar suppliers seeking a new market have been rushing to develop replicas of anti-cancer treatments as the patent of eight highly sought original biomedicines have expired or are approaching expiration from 2015 to 2020 in Europe and the U.S. The combined sales of eight original biomedicines reached $63.5 billion last year.

Worldwide demand for biomedicines including anti-cancer drugs has been also burgeoning following a shift in the global pharmaceutical industry’s focus from synthetic drugs to biomedicines. Biomedicine sales jumped to 23 percent of the global pharmaceutical market in 2014 from 14 percent in 2006, and are forecast to increase to 27 percent in 2020.

By Lee Dong-in

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