Celltrion’s Copy of J&J’s Remicade Gets FDA Staff Support

  • FDA staff calls Celltrion's drug `highly similar' to Remicade
  • The treatment would be the second biosimilar in the U.S.

Celltrion Inc.’s experimental copy of Johnson & Johnson’s best-selling arthritis treatment Remicade gained support from U.S. regulators in a staff report released on Friday.

If eventually approved for sale, Celltrion’s drug, called CT-P13, will be the second-ever in the U.S. from a class of lower-cost versions of brand-name biotechnology drugs known as biosimilars. The medicine is “highly similar” to Remicade, which is sold for inflammatory diseases such as rheumatoid arthritis and psoriasis, Food and Drug Administration staff said in the report. The agency will convene outside advisers Tuesday to discuss the drug further.

“The results of the clinical development program indicate that Celltrion’s data support the demonstration of ‘no clinically meaningful differences’ between CT-P13 and the U.S. Remicade in terms of safety, purity, and potency in the indications studied,” FDA staff wrote.

Treatments like Celltrion’s are copies of complex biologic drugs that are made from living organisms. Typically injected or infused, biologics are often more expensive than simpler pills. Until recently, they had never faced U.S. competition from cheaper, generic versions.

Celltrion studied CT-P13 in rheumatoid arthritis and a disease that can cause some of the vertebrae in the spine to fuse together known as ankylosing spondylitis. The company also provided information to support extrapolation of the data on the two disease to gain approval for the other five conditions Remicade is approved to treat as well, according to the FDA staff report.

Remicade generated $4.45 billion in U.S. sales last year for J&J, according to data compiled by Bloomberg, and competes with AbbVie Inc.’s blockbuster Humira.

CT-P13 was authorized for sale by the European Medicines Agency in 2013, where it is called Remsima. Celltrion has applied for approval of another biosimilar to treat breast cancer and is studying a third in non-Hodgkin’s lymphoma, according to its website. It has an agreement with Pfizer Inc.’s Hospira unit to market CT-P13.

A 2010 law gave the FDA authority to approve biosimilars, with the goal of reducing drug costs by billions of dollars a year. The U.S. may save at least $44 billion in drug spending over 10 years because of the cheaper versions, according to Rand Corp.

Since then, the agency has cleared one biosimilar for sale -- Novartis AG’s copy of Amgen Inc.’s Neupogen. Amgen, meanwhile, has applied to the FDA for approval of a biosimilar version of AbbVie’s Humira.

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