FDA Panel Shows Strong Support for a Remicade Biosimilar

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.

Legal News is part of our ongoing commitment to provide legal insight to our clients and colleagues. If you have any questions about or would like to discuss these topics further, please contact your Foley attorney or any of the following individuals:

Nathan Beaver
Partner
Washington, D.C.
202.295.4039
[email protected]

David Rosen
Partner
Washington, D.C.
202.672.5430
[email protected]