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FDA Panel Shows Strong Support for 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.

© 2020 Foley & Lardner LLPNational Law Review, Volume VI, Number 42


About this Author

Nathan A. Beaver, Foley Lardner, FDA Enforcement Lawyer, Regulatory Attorney,

Nathan A. Beaver is a partner and food and drug lawyer with Foley & Lardner LLP, where his practice focuses on the representation of manufacturers whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics, and foods with special emphasis on the strategic considerations involving the approval...

David L. Rosen, Foley Lardner, FDA Regulatory Lawyer, Life Science Industry Attorney,

David Rosen is a partner and public policy lawyer with Foley & Lardner LLP. Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams.

Mr. Rosen was formerly a partner with two other law firms. He was also employed by the FDA for 14 years, progressing to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues and related compliance activities.