FDA staff signaled support for Celltrion's biosimilar of Johnson & Johnson's ($JNJ) Remicade in documents released ahead of a key panel vote, a positive development for the South Korean company as it works with Pfizer ($PFE) to tap the U.S. market.
Celltrion's biosimilar, marketed overseas as Remsima, proved itself "highly similar" to J&J's blockbuster inflammation therapy across three clinical trials, FDA reviewers wrote. The agency found "no clinically meaningful differences" between the two products, and considers Celltrion's supporting data to be sufficient to support its use in rheumatoid arthritis and ankylosing spondylitis.
Celltrion, partnered with Pfizer, is seeking approval for all of Remicade's cleared indications, which also includes psoriatic arthritis, Crohn's disease, ulcerative colitis and psoriasis. An independent panel of experts is slated to meet on Tuesday to vote on whether Remsima matches up to Remicade and merits approval in each of its reference product's indicated diseases.
The panel meeting is about a year behind schedule, initially set for last February before the FDA delayed it "due to information requests pending with the sponsor of the application," the agency said at the time.
Pfizer inherited the marketing rights to Remsima in its $17 billion acquisition of Hospira, closed last year. The pharma giant abandoned an in-house Remicade biosimilar in favor of Celltrion's version, which is approved in Europe.
J&J has already faced the heat from Celltrion's knockoff in Europe, where it is steadily gaining market share. And J&J execs have been bracing for a challenge to a drug that brings in billions of dollars in the key U.S. market.
J&J, meanwhile, hinted at its planned defensive strategy for the upcoming advisory committee hearing.
"We look forward to Tuesday's FDA Arthritis Advisory Committee meeting and a robust scientific discussion focused on patient well-being as an infliximab biosimilar candidate is discussed," the company said in a statement sent to FierceBiotech. "In testimony at the open hearing, Dr. Jay Siegel, chief biotechnology officer and head, scientific strategy and policy, Johnson & Johnson, will highlight some key facts and concerns for the advisory panel to consider, particularly with respect to extrapolation of indications. Patient well-being is our first priority, and we fully support efforts to implement regulatory standards for the development and approval of biosimilars that ensure there are no clinically meaningful differences between the biosimilars and the reference products with respect to the high standards of safety and efficacy."
- read the briefing (PDF)
John Carroll contributed to this report.