South Korea's Celltrion is aiming to be second in line when biosimilars make their U.S. landfall, filing an FDA application to market a knockoff of Johnson & Johnson's ($JNJ) blockbuster Remicade.
The company is seeking approval for Remsima, a biosimilar of J&J's top-selling anti-inflammatory treatment, which pulled in about $8.4 billion in revenue last year. Celltrion is just the second company to file for approval under the FDA's newly created biosimilar pathway, following Novartis' ($NVS) July application to sell a copy of Amgen's ($AMGN) biological treatment Neupogen. Remsima is the first biosimilar monoclonal antibody submitted to the agency, the company said.
Celltrion expects to win agency approval within a year, giving it stateside clearance for a drug it already markets in more than 50 countries around the world. The company, along with partner Hospira ($HSP), made global headlines last year when the EU approved Remsima for use on the continent, clearing the way for a 2015 launch when the reference drug comes off patent.
J&J's treatment, widely used for rheumatoid arthritis and Crohn's disease, isn't slated to lose U.S. patent protection until 2018, but Celltrion has a plan to get Remsima on the U.S. market before that. The company has filed suit against Janssen, the J&J subsidiary that developed the drug, challenging the validity and enforceability of some remaining Remicade patents.
In a statement, J&J said it's aware of Celltrion's complaint and has filed a motion to dismiss it. The court is yet to rule on the issue, the company said.
Meanwhile, thanks to changing regulations and a looming biotech patent cliff, the global market for biosimilars is poised to boom. According to a report from Allied Market Research, worldwide sales for copycat biologics will reach $35 billion by 2020 after scraping together just $1.3 billion last year, as blockbusters like Humira and Herceptin lose exclusivity.
And Celltrion is positioning itself to cash in. Beyond Remsima, the company has a copy of Herceptin, which brought in $6.6 billion for Roche ($RHHBY) last year; and a take on the same company's Rituxan, which accounted for $7.8 billion in 2013 sales.
"Our U.S. biosimilar BLA application is garnering interest not only from other biosimilar developers, but from healthcare providers and the healthcare industry as a whole," Celltrion said in a statement. "This is because the medical community is aware that the eventual approval of sales of biosimilars in the U.S. market will signal an age where biosimilar (monoclonal antibodies) are globally recognized as innovative, high-quality biologics, with equivalency in both efficacy and safety to their originator products, available to patients in need at a more affordable price."
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