The U.S. Food and Drug Administration on Friday approved Amgen Inc’s biosimilar copy of Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade, according to the regulator’s website.
The biosimilar, Avsola, has the same chemical components, dosage form and strength as Remicade and would treat a range of autoimmune disorders.
Amgen did not give the pricing of the drug immediately, but said is confident to compete in the biosimilar market.
The label for the treatment carries a boxed warning, FDA’s harshest, flagging risks of serious infections and malignancy, similar to that of Remicade’s.
With the regulatory approval, Avsola joins the existing biosimilars to J&J’s drug, including Pfizer Inc’s 2017 approved Ixifi, Celltrion Inc’s Inflectra and Merck & Co and Samsung Bioepis Co Ltd’s Renflexis.
Avsola will add to Amgen’s growing biosimilar unit, which could be $2 billion over the next several years, says Jefferies analyst Michael Yee.
However, Yee doesn’t see the drug as a major driver of sales for Amgen right now.
Avsola was approved for all eligible indications of Remicade, including the treatment of bowel disease, Crohn’s disease and skin disorder plaque psoriasis, the agency said.
Biosimilars are medicines considered highly similar to an original drug and are cheaper alternatives to biologic products.
The blockbuster drug Remicade, approved in the United States, European Union and other regions, has steadily lost market share among patients enrolled in the Canadian province of Quebec’s public drug program and elsewhere, where biosimilars have been slowly catching on with doctors and patients.