The Food and Drug Administration's (FDAs) Arthritis Advisory
Committee gave a thumbs up to a biosimilar copy of Johnson &
Johnson's Remicade product, an inflammation blocker used in the
treatment of rheumatoid arthritis, on Tuesday. In a 21 – 3
vote, the advisory panel voted in favor of approving the biosimilar
CT-P13, produced by Korean company Celltrion, for each of
Remicade's eight indications. The FDA's approval of a
biosimilar — the "equivalent of a generic" for
biologic drugs — for such a wide range of indications would
have a major impact on the industry.
Although the independent panel's decision is not binding on the
FDA, the agency typically follows the recommendation of its
advisory committees. Should the FDA follow suit in approving
CT-P13, it would be only the second biosimilar approved in the
United States, following the approval of Sandoz, Inc.'s Zarxio,
a biosimilar product to Amgen Inc.'s Neupogen (filgrastim), on
March 6, 2015. Given the novelty of biosimilars, an approval by the
FDA would create big waves, especially if it foreshadows increasing
competition from other biosimilars.
We will continue to follow the development and review of this
product, as well as future biosimilar products in the pipeline for
FDA approval, and evaluate the potential impact such approvals, as
well as patent litigation, may have for the broader market.
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