Merck & Co signs biosimilars deal for US veterans

Merck & Co has signed a deal with the US Department of Veterans Affairs (VA) for its inflammatory diseases biosimilar, Renflexis, so that veterans’ care can be improved.

Merck, which is known as Merck Sharp & Dohme (MSD) outside the US and Canada, was awarded the exclusive contract for its tumour necrosis factor (TNF) blocker biosimilar, Renflexis. It has become the only infliximab biosimilar on the VA national formulary.

The US Food and Drug Administration (FDA) approved Renflexis, manufactured by South Korea's Samsung Bioepis, in April last year as a biosimilar to Janssen Biotech’s Remicade (infliximab). The drug has to be injected, as stomach acids would render the medicine ineffective.

Merck & Co and Samsung Bioepis have a deal covering marketing of certain biosimilars dating back to 2013, with the US pharma responsible for marketing, after development by the South Korean firm.

Patrick Magri, senior vice president, US Hospital & Specialty Business Unit, Merck, said: “We are pleased that VA has chosen to expand access to an important treatment option such as Renflexis for our veterans who have nobly served this country.”

And Dr Michael Valentino, chief consultant for pharmacy benefits management at the Department for Veterans Affairs, added: “VA recognises the value biosimilars bring to the health care system, and the award of this contract is consistent with VA’s goal of providing quality treatment options while optimising resources in the care of veterans.”

The drug is an artificial monoclonal antibody that is used to treat several inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis, ulcerative colitis and Crohn’s disease. The treatment can also be used for sarcoidosis when patients do not respond to other medications.

It was developed in mice as a mouse antibody and has been altered so that humans can use the medicine. The antibodies have identical structures and affinities to the target.

In August, the Canadian province, British Columbia, added Renflexis to its list of drugs that attract reimbursement. The biosimilar is approved in Canada to treat a range of disorders, including inflammatory bowel diseases and inflammatory arthritis.