HONG KONG – South Korean conglomerate Samsung's biosimilar arm, Samsung Bioepis Co. Ltd., is well under way in expanding its global presence by pushing multiple blockbuster biosimilars into major markets around the world.

On Monday, the soon-to-be-listed company said the European Commission (EC) approved its biosimilar version of Johnson & Johnson's blockbuster drug, Remicade (infliximab), which marks another milestone for a relatively late-comer in the biopharma industry. The drug, Flixabi, will be marketed in Europe by Biogen Inc.

It marks the second infliximab biosimilar approved for marketing in Europe. The first was Remsima, developed by another Korean company, Celltrion Healthcare Co. Ltd., in June 2013 and marketed since 2014. Remsima is commercialized by Pfizer Inc.

"As far as European markets are concerned, this is a direct competition between Celltrion's partner and Bioepis' partner," said Park Jae-Cheol, senior biopharmaceutical and health care analyst at Mirae Asset Securities.

"Celltrion's biggest strength is that it's an early comer in the biosimilar market. Samsung's strength lies in its partnership with Biogen. It's difficult to predict whether Samsung would be able to take Celltrion's market share," Park told BioWorld Today. "Samsung's partner Biogen has a market cap of $62 billion, and in the past 10 years it has been one of the most successful biotech companies."

Pfizer's market cap is at $210 billion.

Ultimately, the sales figures of the new biosimilars in the European market will rest on the commercialization partner's ability to effectively market the drugs in the key regions.

"In some markets, Celltrion is really enjoying an autonomous status. For example, the health care system in Norway isn't private; Celltrion dominates 90 percent of the market there with its cheaper pricing. So this [competition] will really come down to marketing in major markets like France, [the] U.K., Spain and Italy," Park told BioWorld Today.

Flixabi, also known as SB2 in the Bioepis pipeline, treats rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. The EC approval of Flixabi applies to all 28 EU member states as well as the European Economic Area (EEA) where member states include Norway, Iceland and Liechtenstein.

"With this approval, we are taking another important step in broadening affordable, high-quality biologic treatment options across Europe," said Christopher Ko, president and CEO of Samsung Bioepis.

In a 54-week phase III study, Flixabi showed comparable safety and equivalent efficacy to originator Remicade. According to ACR20 criteria, it recorded 65.3 percent response rate compared to the 69.2 percent response rate of the original drug.

The study was done among 584 random patients with moderate to severe rheumatoid arthritis who had received last-resort methotrexate therapy, across 73 sites in 11 countries.

BEYOND EUROPE

The competition between the two companies doesn't stop at Europe. Just days before receiving the greenlight from the EU, Flixabi was accepted by the FDA for reviewing. That means the FDA started reviewing Bioepis' application merely two months after it approved Celltrion's biosimilar infliximab (sold as Inflectra in the U.S).

Remsima has already been approved in 71 countries. With Bioepis' approvals rolling out from different jurisdictions, analysts expect the competition between Celltrion and Samsung to grow steeper overseas.

SB2 is also Samsung's first biosimilar candidate submitted for review in the U.S. It will be commercialized by Merck & Co. Inc. upon approval. Bioepis established the commercialization partnerships with Merck and Biogen in 2013.

Meanwhile, Samsung Bioepis' parent company, Samsung Biologics, has recently opened its third manufacturing plant in Incheon, South Korea. In terms of return on investment, Samsung Biologic's manufacturing plant is capable of producing biologics at around 43 percent of the cost of its global competitors, according to Samsung's calculations based on investment capacity ratios.

Currently, Samsung Biologics is planning an IPO in South Korea by the end of the year, and analysts estimate that the IPO could raise up to KRW3 trillion (US$2.5 billion). Bioepis is planning a Nasdaq debut as well.