HONG KONG – Marking another step forward for South Korea's leading biosimilar developer, the Ministry of Food and Drug Safety (MFDS) approved domestic sales of Samsung Bioepis Co. Ltd.'s Renflexis (infliximab), a biosimilar of Johnson & Johnson's Remicade (infliximab). This is the second marketing approval for the company this year.

"Our aim is to bring affordable, high-quality biologic treatment options to patients who need them most. The advances we have made this year with Brenzys (SB4) and Renflexis (SB2) bring us a step closer to realizing this goal, which has been made possible by our strengths in product development and quality assurance," Samsung Bioepis' spokesperson Min-gi Hyun told BioWorld Today.

Renflexis can be used to treat various autoimmune disorders like rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis in adult patients 18 and older.

The biosimilar is the first self-developed biosimilar in the South Korean market. It spawned from a partnership between Samsung Bioepis and Merck Sharpe and Dome (MSD), also known as Merck & Co. Inc.

MSD Korea will distribute Renflexis and is planning to put the treatment on the market by the first half of 2016.

Renflexis demonstrated comparable safety and equivalent efficacy to Remicade during a 54-week phase III study of 584 randomized patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.

The study was done across 73 sites in 11 countries.

"We look forward to the introduction of Renflexis in Korea, where patients suffering from autoimmune diseases will soon have access to an affordable, high-quality biologic treatment option," Christopher Hansung Ko, president and CEO of Samsung Bioepis, stated in a release.

Samsung Bioepis' now has two biosimilar products with marketing approval in South Korea. Domestic sales of Brenzys started Dec. 3. The MFDS gave its approval in September.

Brenzys is the firm's biosimilar. The originator drug is Enbrel (etanercept), the best-selling rheumatoid arthritis treatment developed by Amgen.

Multiple clinical tests on Brenzys have shown the drug to be as effective and safe as the originator while the cost is much lower. The costs of Brenzys is about 33 percent lower than Enbrel at about SKW141,976 (US$123) for one 50 mg dose injection.

Samsung Bioepis and MSD's collaboration to commercialize anti-TNF biosimilar product candidates goes back to February 2013, a year after the South Korean conglomerate's subsidiary Samsung Lifescience launched Samsung Bioepis through a joint venture with Biogen Inc., of Cambridge, Mass. The aim of the joint venture is to tap deeper into the South Korean biotech industry and develop products with global reach.

Samsung Bioepis has also successfully completed phase III trials for its Humira biosimilar SB5 (adalimumam), while Herceptin biosimilar SB3 (trastuzumab) and Sanofi AG's Lantus biosimilar SB9 (insulin glargin) are also undergoing trials.

With this pipeline, Samsung Bioepis has found an edge over South Korea's Celltrion Inc., of Incheon, South Korea.

SB5 is where Samsung Bioepis has an edge over Celltrion, its closest competitor in the biosimilars space.

"[Samsung] Bioepis is the only South Korean company to have successfully completed the third phase clinical trial of the biosimilar for Humira, while Celltrion is still at the preliminary stage for clinical trials for the [Humira] biosimilar," Park Jae-Cheol, an analyst from Mirae asset management told BioWorld Today.

"Biosimilars are now starting to take market share of original drugs like Humira, Remicade and Enbrel. Now, it is more of a marketing competition between these biosimilar companies," said Park.

Samsung Bioepis has a pipeline of 13 biosimilars under development.

And with patents expiring in the near future for a number of drugs, including Remicade in Europe next year, there are significant opportunities for growth.

Samsung Bioepis is also considering a Nasdaq listing sometime next year.