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FDA Approves New Drug That Could Take a Slice Out of Johnson & Johnson’s Best Seller

A high price for a groundbreaking treatment.A high price for a groundbreaking treatment.
A high price for a groundbreaking treatment.Photograph by Dwight Eschliman—Getty Images

Pharma giant Johnson & Johnson’s Remicade brought in nearly $7 billion in sales last year. But Samsung Bioepis and partner Merck are hoping to claw away some of that market share with a new rival therapy—one that could come at a significant discount to the pricey arthritis and psoriasis treatment, which is J&J’s best-selling product by far.

The Food and Drug Administration (FDA) has given the green light to Renflexis, which is now the second approved “biosimilar” of Remicade in the U.S. (the first was Pfizer’s Inflectra, approved last April). Biosimilars mimic biologic drugs, which, as the name implies, are derived from biological matter rather than chemicals. They tend to be much more expensive than conventional medicines and are some of the most lucrative pharma products in the world.

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Since biosimilars are so new to the U.S. market (there have been just five total approved here since 2015), it’s been hard to gauge whether or not they can make a formidable dent in high drug prices by offering generic alternatives to branded treatments. The initial signs haven’t been all that encouraging; for instance, Pfizer announced last fall that it would price Inflectra at just a 15% discount to Remicade. Some had hoped to see a price cut of up to 30%. And in Europe, biosimilars have driven down the prices of some drug types by as much as 50%.

Samsung Bioepis, which has a pipeline of these kinds of copycat treatments for a number of flagship therapies, specifically cited the price-cutting potential of biosimilars.

“Since our company was established five years ago, we have strived day in and day out to realize the promise of biosimilars for patients across the United States by offering them treatment options at a lower cost. We hope this regulatory milestone will bring us a step closer to achieving this goal,” said Christopher Hansung Ko, President & CEO of the firm, in a statement.

But Samsung Bioepis and Merck, which will be responsible for marketing and distributing the drug in the U.S.—somewhat ironic given that Merck actually markets branded Remicade in Europe in a partnership with J&J—haven’t disclosed just what the price will be quite yet. The companies say they will announce it much closer to the product’s launch later this year.