Celltrion Inc., South Korea’s leading biopharmaceutical company, said on Wednesday that it has received marketing authorization from the U.S. Food and Drug Administration (FDA) for Remsima, its first antibody biosimilar, making the way to for selling the drug in the world’s largest pharmaceutical market.

The FDA said that Remsima - a biosimilar version of Johnson & Johnson’s Remicade (infliximab) - is effective for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, pediatric and adult Crohn’s disease, psoriasis, and psoriatic arthritis. Remsima has the same indications as Remicade.

With the green light given by the FDA, Celltrion expects to earn up to 2 trillion won ($1.7 billion) a year in the U.S. market. U.S. sales of Remicade amounted to $4.5 billion in 2014.

Revenue of entire TNF-alpha inhibitors reaches about $17.2 billion in the U.S. If Celltrion catches 10 percent here, its annual sales will gain 2 trillion won.

In the U.S., drug prices are determined by negotiations between insurers and manufacturers. As a result, novel drugs experience a rapid price fall when their patent protection expires, Celltrion said. Generic preion in the U.S. stands high at 88 percent.

The U.S. was passive toward market opening to biosimilars to protect its own pharmaceutical industry. In contrast, Europe has been actively introduced biosimilars since the mid-2000s to reduce the burden on healthcare spending.

But the situation changed in the U.S. with an increasingly aging population and the need for extensive care. The FDA approved Zarxio, a biosimilar drug to treat neutropenia and the first biosimilar approved in the U.S., last March and approved Remsima this year. Remsima is the first approved antibody biosimilar in the U.S.

Biosimilars are near-copies of biologic drugs, which are produced in living cells rather than by mixing chemicals. They are as effective as their reference drugs but are cheaper. Biologics are excellent in efficacy with fewer side effects than synthetic drugs. But as developing biologics is challenging, making biosimilars requires a high level of technology.

Remsima was first approved by the Ministry of Food and Drug Safety in Korea 2012 and by the European Medicines Agency (EMA) in 2013. The company submitted an NDA to the FDA for the in August, 2014, and the FDA advisory panel recommended approval in February.

Meanwhile, Pfizer Inc. will be responsible for marketing and sales of Remsima in the U.S. The biosimilar will be sold under the name of Inflectra in the country from as early as July.

By Lee Dong-in

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