By Kim Tae-gyu
Korean pharmaceutical firm Celltrion shipped the first batch of its biosimilar medicine Remsima to the U.S. Friday, a day after winning a U.S. lawsuit on sales of the autoimmune disorder drug.
Celltrion said that the move will accelerate the U.S. launch of Remsima, a biosimilar version of Janssen's Remicade. Remsima was put on sale in Europe in 2013.
Pfizer will take charge of sales of Remsima in the U.S., which will soon be available to U.S. patients suffering from rheumatoid arthritis and ulcerative colitis under the brand name of Inflectra in the world's largest pharmaceutical market.
"There remain more procedures before the biosimilar medicine actually hits the U.S. market. Pfizer will put forth efforts to deal with them although we will keep cooperating," a Celltrion official said.
"We believe that our victory in the patent suit cleared the biggest hurdle, which prompted us to start shipment."
Seeking a preliminary injunction to prevent Celltrion from selling Remsima, Janssen filed a complaint in June, two months after the drug received approval from the Federal Drug Administration (FDA).
But the district court ruled against Janssen this week and the firm plans to appeal the decision to an upper court. Yet, Celltrion said that the verdict would not be overturned.
"That's why we are starting to send our products to the U.S. We will put forth efforts to speed up all the necessary procedures," the official said.
Celltrion expects that the U.S. debut of Remsima will boost the company's bottom line as the U.S. autoimmune disease medicine market is estimated to be bigger than $17 billion a year.
Its original drug Remicade, which was developed by Janssen in 1998, had sales of $4.5 billion in the U.S. and $9.9 billion worldwide last year, making it one of the world's most profitable blockbuster medicines.
In a press conference this April, Celltrion CEO Kim Hyoung-ki projected that the company will earn more than $1.7 billion in the U.S. next year, assuming a double-digit market share.
The CEO said at the press conference that the biosimilar medicine will be on the shelf "in the fourth quarter of this year."
In Europe, the firm said that Remsima accounts for more than 30 percent of the market and the proportion would increase to somewhere between 40 percent and 50 percent.
"Based on the trust of European physicians and patients, we expect that penetration into the U.S. market will take place at a much faster pace," the company said in a statement.
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| Celltrion CEO Kim Hyoung-ki |
Celltrion said that the move will accelerate the U.S. launch of Remsima, a biosimilar version of Janssen's Remicade. Remsima was put on sale in Europe in 2013.
Pfizer will take charge of sales of Remsima in the U.S., which will soon be available to U.S. patients suffering from rheumatoid arthritis and ulcerative colitis under the brand name of Inflectra in the world's largest pharmaceutical market.
"There remain more procedures before the biosimilar medicine actually hits the U.S. market. Pfizer will put forth efforts to deal with them although we will keep cooperating," a Celltrion official said.
"We believe that our victory in the patent suit cleared the biggest hurdle, which prompted us to start shipment."
Seeking a preliminary injunction to prevent Celltrion from selling Remsima, Janssen filed a complaint in June, two months after the drug received approval from the Federal Drug Administration (FDA).
But the district court ruled against Janssen this week and the firm plans to appeal the decision to an upper court. Yet, Celltrion said that the verdict would not be overturned.
"That's why we are starting to send our products to the U.S. We will put forth efforts to speed up all the necessary procedures," the official said.
Celltrion expects that the U.S. debut of Remsima will boost the company's bottom line as the U.S. autoimmune disease medicine market is estimated to be bigger than $17 billion a year.
Its original drug Remicade, which was developed by Janssen in 1998, had sales of $4.5 billion in the U.S. and $9.9 billion worldwide last year, making it one of the world's most profitable blockbuster medicines.
In a press conference this April, Celltrion CEO Kim Hyoung-ki projected that the company will earn more than $1.7 billion in the U.S. next year, assuming a double-digit market share.
The CEO said at the press conference that the biosimilar medicine will be on the shelf "in the fourth quarter of this year."
In Europe, the firm said that Remsima accounts for more than 30 percent of the market and the proportion would increase to somewhere between 40 percent and 50 percent.
"Based on the trust of European physicians and patients, we expect that penetration into the U.S. market will take place at a much faster pace," the company said in a statement.
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