Celltrion’s biosimilar is accepted by FDA in U.S.
The Incheon-based company announced Wednesday that it received the permission from the U.S. Food and Drug Administration (FDA) for its biosimilar on Tuesday (U.S. time). A biosimilar refers to a close copy of a marketed biotech drug with a less expensive price tag.
A knockoff of Remicade, an original drug developed by Johnson & Johnson, Inflectra is designed to treat autoimmune diseases such as rheumatoid arthritis, inflammatory bowel diseases and Crohn’s disease. It is known as Remsima in Korea.
Biosimilars play a similar role in the marketing and sales of biological products, which use living cells, as generics do for chemical-based drugs.
“The company could get first mover advantages in the biosimilar industry as it enters the U.S., the world’s largest biopharmaceutical market,” the company said in a statement. It estimated the U.S. market for chimeric monoclonal antibody products like Inflectra at 5.4 trillion won ($4.6 billion).
“We predict the biosimilar [Inflectra] will post annual sales of 1 trillion won by 2017,” said Kim Hyoung-ki, Chief Executive Officer of Celltrion, during a media briefing at the Four Seasons Hotel in central Seoul.
The CEO added that the company is on track to develop other biosimilars that it hopes to market both at home and abroad.
The approval marks a major milestone for Celltrion following regulatory green rights for the product from Europe and Japan as well as Korea. The U.S. is considered one of the toughest drug approval regimens in the world.
“As one of the first companies to navigate the biosimilar approval pathway with the FDA, we believe this approval will be an essential step in helping to clarify the application process for these critical medicines,” Kim said.
He added that Inflectra has a 40 percent market share in the antibody biosimilar sector in the European market, where Celltrion already sells the product.
With the U.S. approval, Inflectra will be sold in a total of 71 countries. U.S. drug giant Pfizer is licensed to market it in the U.S.
Celltrion will consult with Pfizer to decide a specific time schedule to sell the treatment, though market watchers predict that the product will become available at the end of this year.
“Considering biosimilar-related rules, we expect that Inflectra will hit the market around October,” said Lee Seung-hoon, a researcher at NH Investment & Securities.
The Arthritis Advisory Committee at the FDA concluded that there is “no clinically meaningful differences between Inflectra and U.S.-licensed Remicade in terms of the safety, purity, and potency of the product,” according to Celltrion.
Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.
Inflectra is the first biosimilar monoclonal antibody to be approved by the FDA and the second biosimilar authorized by the federal agency.
Celltrion has a range of biosimilars under development and 12 products have undergone clinical tests.
The approval, however, doesn’t necessarily mean that Celltrion cleared all hurdles facing Inflectra.
Johnson & Johnson filed a lawsuit against Celltrion in federal court in Massachusetts last year, saying its drug would infringe patents for Remicade. Celltrion denied the allegation.
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