Celltrion, a South Korean bio-pharmaceutical firm, announced on April 6 (Korean time) it has won the final approval from the U.S. Food and Drug Administration (FDA) to sell its biosimilar Remsima, the cheaper replica of Johnson & Johnson's top selling drug Remicade, in the United States.
The bio-medical product is used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine.
What's meaningful is that Remsima is the world's first biosimilar of Remicade to set foot on the U.S. market and is the second biosimilar approved by the FDA following Zarxio, a biosimilar made by Novartis AG, which is replica of Amgen's white blood cell-boosting drug Neupogen.
Approved in 1998 first, Remicade generated an annual global sales of US$6.5 billion last year. Of that, US$4.5 billion were earned in the United States.
Remsima, sales of which will start in the third quarter this year under the name of Inflectra in the United States, is expected to reach annual sales of up to US$1.7 billion. Pfizer will be in charge of marketing and sales of the product in the United States.
Celltrion first got the approval from the Korean Ministry of Food and Drug Safety in 2012 and then from the European Medicines Agency in 2013. It's being sold in about 70 countries worldwide.
Celltrion CEO Kim Hyoung-ki told in a press conference on April 6 (Korean time) that Inflectra is likely to be priced around 20 to 30 percent lower than the generic Remicade in the American market, but the final price would be decided after discussions with its marketing partner Pfizer.