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Merck & Co. secures VA contract to supply Remicade biosimilar


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Merck & Co. secures VA contract to supply Remicade biosimilar

Merck & Co. Inc. secured a national contract to supply Renflexis — its biosimilar of Johnson & Johnson's blockbuster biologic Remicade — to the U.S. Department of Veterans Affairs, or VA.

The U.S.-based pharmaceutical giant said in its Oct. 4 news release that Renflexis, also known as infliximab, was placed on the VA National Formulary as it was "determined to be the lowest priced offer."

Renflexis was introduced in the U.S. in July 2017 at a list price of $753.39, representing a 35% discount to Remicade's list price, Merck had said in a press release during the launch of the medicine.

Merck did not disclose financial details of the VA contract in its Oct. 4 release.

Renflexis was approved by the U.S. Food and Drug Administration in April 2017 as a biosimilar to rheumatoid arthritis drug Remicade. Biosimilars — lower-cost versions of biologics — must show that they are highly similar to an already approved biologic and have no clinically meaningful differences in safety and effectiveness from the referenced innovator products.

In the U.S., Renflexis has been approved for treating Crohn's disease in children and adults, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Meanwhile, Remicade has approval to treat pediatric ulcerative colitis.

Kenilworth, N.J.-based Merck has given manufacturing rights for Renflexis to South Korean biopharmaceutical company Samsung Bioepis Co. Ltd. but retained marketing rights for the biosimilar in the U.S.

Need to boost biosimilars

The addition of Renflexis to the VA National Formulary comes at a time when the FDA has expressed concern at the pace at which the U.S. biosimilars market is growing.

So far, only 12 biosimilars have been approved by the U.S. regulator, and of the 12 just four launched in the market due to ongoing patent litigations or settlements for the others.

Wayne Winegarden, a senior fellow in business and economics at the Pacific Research Institute, recently said that patients and government health programs that cover seniors and the disabled could be missing out on millions of dollars in savings. A June study from the institute found that the annual per patient savings from using the biosimilar version of Remicade could range between $2,100 and $4,400, Winegarden said.