US regulators have approved Renflexis, a biosimilar referencing Johnson & Johnson’s tumour necrosis factor (TNF) blocker Remicade (infliximab), across all eligible indications.
The decision means that physicians will be able to prescribe the drug for reducing signs and symptoms in patients with adult and paediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and for the treatment of adult plaque psoriasis.
However, because of a mandatory six-month notice period, the drug can’t be launched in the country for at least six months, although this is reportedly currently being challenged in the Supreme Court.
Renflexis is the first Samsung Bioepis product approved for marketing in the country, but its infliximab biosimilar is already approved for marketing in 28 European Union member states as well as Norway, Liechtenstein, Iceland, Australia and Korea.
Pricing information is not yet available, but biosimilars are generally coming onto the market at up to 30 percent less than their reference products.
Remicade currently pulls in annual sales of more than $8 billion a year.