US Regulatory Panel Votes in Favor of Remicade Biosimilar

February 10, 2016

On Tuesday, February 9, 2016 an advisory panel to the Food and Drug Administration (FDA) voted that the agency should approve a sale of the copy version of Remicade (infliximab), a Johnson & Johnson (J&J) arthritis drug. According to The Wall Street Journal, infliximab had US sales of $4.45 billion in 2015. The copy was developed by Celltrion Inc and licensed to Pfizer Inc.

The FDA is not required to adhere to the votes of the advisory panel, however, it often does. The vote in favor of infliximab, a biosimilar, could be encouraging for future biosimilars as it might mean the FDA could require less criteria for marketing approval than some people expected, The Wall Street Journal report.

While this US regulatory panel vote may be a positive for companies developing lower-cost copies of expensive biotechnology drugs, the process of marketing knockoffs for infliximab and other top-selling biotech brands may be difficult.
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The Wall Street Journal reported that drug makers, such as AbbVie, Amgen, and J&J, are requesting new US patents for their original drugs in attempts to prevent such copies, also referred to as biosimilars, from being developed. These patents have the potential to delay the admission of competing copies, “well beyond when the FDA clears them for sale, and beyond the expirations of the branded drugs’ original patents, which are due in coming months and years.”

Chris Raymond, biotech analyst, Raymond James, stated that these persistent patent efforts mirrors the “hefty” profits and sales that are at stake for the biotech brand manufacturers. He revealed that the patents could indeed “pose a big barrier” to these potential biosimilars.

“It’s just a lot more complicated to make a biologic. That leads to more patents,” said Zachary Silbersher, patent attorney, Markman Advisors. Silbersher revealed that the volume of patents also reflects the convoluted nature of biotech drugs, which are usually manufactured in living organisms—rather than through the chemical synthesis used for regular drugs.

A final decision on Celltrion’s product is expected later this year.—Alessia D’Anna

Reference: Loftus P. Panel recommends the FDA approval of Remicade knockoff. The Wall Street Journal. February 9, 2016.