LDN - Health and Fitness

Merck, Samsung Bioepis launch discounted U.S. Remicade alternative

[July 25, 2017] NEW YORK/SEOUL (Reuters) - Merck & Co and South Korea's Samsung Bioepis Co Ltd said on Monday they have begun selling a less expensive alternative version of Johnson & Johnson's rheumatoid arthritis drug Remicade in the United States, a move that should accelerate price declines for the big-selling medicine.

The U.S. and Korean drugmakers said they would sell their version, to be called Renflexis, at 35 percent discount to the list price of J&J's top-selling medicine, or about $735 for a 100 milligram dose.

J&J shares were down 1.6 percent at $133.16.

Renflexis is the second U.S. biosimilar version of Remicade to be sold after Pfizer Inc launched its Inflectra late last year at a 15 percent discount to J&J's list price, later dropped to a 19 percent discount.

Remicade had U.S. sales of $4.8 billion last year. They fell 8.2 percent for the first half of 2017 to $2.2 billion with the new competition.

As with generic medicines, once multiple biosimilars of a drug become available prices are expected to drop more quickly. Many industry executives and analysts have expressed surprise at how fast prices have fallen in Europe, which led the way with biosimilars.

Merck sells the branded version of Remicade outside the United States. In Europe, it is already facing competition from biosimilar Remicade and cheaper versions of other medicines in the class.

Many companies are developing a wide range of biosimilar versions of top-selling biologic medicines, including major biotechs like Amgen Inc, which is working on cheaper versions of several of its rivals' blockbuster drugs.

J&J, in a statement, said it offers a variety of discounts and rebates off the list price of Remicade, giving it an average sales price of $808.87 per 100mg vial.

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J&J's Janssen unit sought a preliminary or permanent U.S. injunction to block the Bioepis version, arguing that it infringed three of its patents. A hearing for the lawsuit has yet to be scheduled.

"We are confident we do not infringe on Janssen's patents," Samsung Bioepis spokesman Mingi Hyun said.

Renflexis, which received U.S. approval in April, is the first medicine available in the United States under a global biosimilars agreement between Merck and Samsung Bioepis, a unit of Samsung BioLogics Co Ltd.

Since it is not possible to make exact copies of complex biotech medicines, which are manufactured from living cells, they cannot be called true generics as with simple pills. Instead, companies must prove their versions are similar enough to the original medicine.

(Reporting by Bill Berkrot in New York and Se Young Lee in Seoul; Additional reporting by Ben Hirschler in London; Editing by Edwina Gibbs and Matthew Lewis)

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