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.
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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.